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78 Jobs Found 

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Research & Development Engineer

Cook Group

Limerick
18 days ago
Limerick
18 days ago

Overview

Design, development and taking to market of medical devices for one or more Cook Medical Strategic Business Units.

 

 

Reporting to: Senior Research & Development Engineer/Research & Development Manager  

 

 

 

Find out more about Cook Medical here

Responsibilities

  • Perform Duties of Research & Development Engineer including:
    • Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
    • Product testing and evaluation, completion of test reports to support design selection.
    • Preparation and presentation of design reviews.
    • Product and project risk analysis and risk management.
    • Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
    • Source new materials components and equipment.
    • Development of component specifications, inspection methods, bills of materials and manufacturing processes.
    • Introduction of new equipment, materials and technologies.

 

  • Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.

 

 

  • Project lead for assigned research & development projects including technical and project management responsibly.
    • Manage and drive project tasks to ensure timely completion of project milestones.
    • Work closely with cross functional groups to achieve project and company goals.
    • Product performance evaluations.
    • Contribute to innovation and creativity within team through filing of disclosures and patents.
    • Hold regular project meetings and document minutes and actions.
    • Ensure project milestones are achieved to meet business metrics.

 

 

 

  • Compliance with Quality, Regulatory and company policies and systems.
  • Communications:
    • Regular communication to cross-functional teams, senior management and business unit leaders.
    • Project status communications and reporting.
  • Remain on the forefront of emerging industry practice

 

 

  • Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
  • Support other cross functional groups to deliver company goals.#
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

 

Qualifications

  • Third level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
  • 2 Years design experience medical device roles.
  • Project planning skills.
  • Execution of project in a timely effective manner.
  • Knowledge of anatomy and physiology.
  • Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Manufacturing design and process understanding.
  • Good working knowledge of Solidworks and/or Pro Engineer CAD.
  • Strong technical writer.
  • Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745.
  • Team Player with ability to develop strong working relationships.
  • Strong communication and inter-personal skills.
  • Good problem solving skills.
  • Highly motivated individual, self-starter with a passion for excellence.
  • Must be able to work in a fast paced environment.
  • Willingness and availability to travel on company business.

 

 

 

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Manufacturing Team Member

Cook Group

Limerick
30+ days ago
Limerick
30+ days ago

The primary function is to assist in the manufacturing & shipment of medical device products.

 

Reporting to: Production Supervisor  

 

 

Find out more about Cook Medical here


  • Carry out any process steps required for the manufacture & shipment of high quality medical devices products.
  • Adherence to COOK Quality system procedures and all associated manufacturing documentation which is provided to employees in order to assist them in the manufacture & shipment of high quality products.
  • Responsible for the completion of training in relation to the manufacture & shipment of product.
  • Ensure that a high standard of GMP and housekeeping is maintained in all manufacturing areas.
  • Adherence to all Environmental, Health and Safety requirements in accordance with company Policies.
  • Highlight any potential issues to team leaders/Supervisors.
  • Provide flexibility in working on any other tasks that may arise during the course of a normal day in a production environment.
  • May perform other duties as assigned by Supervisor.
  • Working as part of a team within the Production area.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

  • Experience in a production environment preferred.
  • Previous experience in medical devices, while not essential is advantageous.
  • Good communication and inter-personal skills.
  • Ability to work as part of a team.
  • Some flexibility as regards working hours/days.
  • Willingness and availability to travel on company business
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Manufacturing Team Member

Cook Group

Limerick
30+ days ago
Limerick
30+ days ago

Overview

The primary function is to assist in the manufacturing & shipment of medical device products.

 

Reporting to: Production Supervisor  

 

 

Find out more about Cook Medical here

Responsibilities

  • Carry out any process steps required for the manufacture & shipment of high quality medical devices products.
  • Adherence to COOK Quality system procedures and all associated manufacturing documentation which is provided to employees in order to assist them in the manufacture & shipment of high quality products.
  • Responsible for the completion of training in relation to the manufacture & shipment of product.
  • Ensure that a high standard of GMP and housekeeping is maintained in all manufacturing areas.
  • Adherence to all Environmental, Health and Safety requirements in accordance with company Policies.
  • Highlight any potential issues to team leaders/Supervisors.
  • Provide flexibility in working on any other tasks that may arise during the course of a normal day in a production environment.
  • May perform other duties as assigned by Supervisor.
  • Working as part of a team within the Production area.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Experience in a production environment preferred.
  • Previous experience in medical devices, while not essential is advantageous.
  • Good communication and inter-personal skills.
  • Ability to work as part of a team.
  • Some flexibility as regards working hours/days.
  • Willingness and availability to travel on company business
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Quality Inspector

Edwards Lifesciences

Shannon
30 days ago
Shannon
30 days ago
Assesses devices in-process and upon completion, reviews accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed.
Key Responsibilities:
• Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements
• Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications
• Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks
• Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction
• Perform line clearance and verification of inspection
• Perform verification of manufacturing documents with component and device drawings
• Support the training of other inspectors through work demonstration and feedback
• May ensure smooth shift transitions by providing status de-brief of shift activities
• Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties: General work area housekeeping
Education and Experience:
2 years years experience of previous related experience, including GMP and GDP Required
H.S. Diploma or equivalent Preferred
Additional Skills:
• Good communication skills
• Able to read, comprehend, speak, and write English
• Basic computer skills, required, including working knowledge of manufacturing software
• Strict attention to detail
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity
• Full understanding of applicable inspection procedures
• Continuously expands proficiency in inspection techniques
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
• Must be able to work in a team environment and with minimum supervision by following detailed work instructions
• Ability to effectively provide and accept feedback from colleagues
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Regulatory Affairs & Communications Specialist

Cook Group

Limerick
15 days ago
Limerick
15 days ago

Overview

The Regulatory Affairs Specialist - Regulatory Communications serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS, PMCF, CER) and associated correspondence to applicable Regulatory bodies.

 

 

 Reporting to:               Senior Regulatory Affairs Specialist   

 

 

Find out more about Cook Medical here

Responsibilities

  • Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
  • Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.
  • Generate appropriate regulatory reports based on assessment.
  • Liaise effectively with regulators on all issues with regard to regulatory reporting.
  • Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
  • Communicate with other Cook Companies globally as necessary for reporting.
  • Generate responses to inquiries on AE reports from various global regulatory authorities.
  • Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
  • Assist in coordination of Recall / Field Action administration activities between manufacturer and distribution centre.
  • Reviewing and approving reports and responses as necessary.
  • Close out of complaints as necessary.
  • Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Liase and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same.
  • Maintain an excellent understanding of global medical device regulations.
  • Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Performs additional duties as assigned.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Third level Qualification in Science/Engineering desired.
  • A number of years experience in a regulated industry in a similar role required.
  • Thorough knowledge of the EU & US medical device regulatory requirements.
  • Knowledge of regulatory requirements in MDSAP countries.
  • Desirable to have knowledge of requirements in other jurisdictions.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft®
  • Proven organisational skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.

About Cook Medical

Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.

 

Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

 

Regulatory in Limerick

Our RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.

 

Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.

 

Our employee benefits include:

  • Life Assurance and Income Protection cover
  • Educational Assistance
  • Company sponsored Defined Contribution pension scheme
  • Medical Health Insurance cover for you and your immediate family
  • Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
  • Fully equipped gym on site
  • 39-hour week with flexible start & finish times
  • Paid time off to participate in volunteer activities
  • Free parking
  • Subsidised restaurant
  • Sports & Social club
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Senior Supplier Quality Engineer

Edwards Lifesciences

Shannon
1 day ago
Shannon
1 day ago
Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Key Responsibilities:
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree or Equivalent in in Engineering or Scientific field , 4 years years experience of industry experience or industry/education Required or
Master's Degree or equivalent in in Engineering or Scientific field , 3 years years experience of industry experience or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field industry experience or industry/education
Additional Skills:
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Warehouse Clerk

Edwards Lifesciences

Shannon
18 days ago
Shannon
18 days ago
Supports specified Warehouse and/or Distribution operation by performing related area material handling functions for shipping, receiving, and raw materials (including limited chemical handling) in accordance to Edwards' policies and procedures.
Key Responsibilities:
• Material requisition fulfillment, including locating, verifying, and labeling requested materials, and performing required system transaction and delivering materials to the area specified on the requisition, in keeping with established work instructions and SOPs
• Receive materials into the warehouse from production returns and/or QA released purchase orders, verify count of goods received and transfer to physical stock location accompanied by the appropriate JDE transaction.
• Perform weekly inventory cycle counts and annual physical inventory count (if required) resolving any discrepancies identified during the process.
• Contribute to improvement activities and participating in lean initiatives. Assist with inventory and/or system problem resolution
• Perform equipment inspection of all lift equipment prior to operation.
• Other incidental duties: General housekeeping of work area and LMS Training
Education and Experience:
2 years experience of related experience in a warehouse environment and forklift operation required
Additional Skills:
• Strong verbal and written communication skills
• Good organizational skills, able to prioritize and manage competing priorities, detail oriented and quality focused
• Ability to read, interpret and comprehend policies and procedures (English Speaking, preferred)
• Must have strong communication skills, both verbal and written.
• Ability to complete paperwork accurately following good documentation practices (GDP)
• Ability to perform basic math calculations including adding, subtracting, and measuring
• Forklift certification required within applicable area
• Critical thinking and problem solving skills required
• Ability to lift 25-50 lbs unassisted (based on need)
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to warehouse operations and clean room medical device manufacturing
• Must be able to work with minimum supervision by following detailed instructions
• Work in a team environment, including exchanging information related to performing required tasks with colleagues and with internal customers, as well as with vendors and carriers
• Basic computer skills required; good working knowledge of warehouse (enterprise) system
• Flexibility to work varying shifts and/or overtime, as needed
• Strict attention to detail and accuracy
• Basic computer skills required
• Good working knowledge of warehouse (enterprise) system
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Manufacturing Technician

Cook Group

Limerick
7 days ago
Limerick
7 days ago

Overview

The primary purpose of this position is to provide technical support to operations in the following areas:

  • Assist Engineers to develop production processes and ongoing process improvements.
  • Ensure the efficient transfer of prototype and pilot products to full production status and support these product lines on an on-going basis.
  • Preparation of change control documentation in order to ensure timely processing of sister company change requests.
  • Develop component and product drawings required by sister Company change requests.
  • Assist in product development activity as required by Supervisor.
  • Provide technical support for manufacturing processes as required by Supervisor.

 

Reporting to: Senior Manufacturing Engineer/ Manufacturing Engineer  

 

 

Find out more about Cook Medical here

Responsibilities

  • Assist engineers to develop production processes and ongoing process improvements.
  • Ensure the efficient transfer of prototype and pilot products to full production status and support these product lines on an on-going basis.
  • Provide technical support for manufacturing processes as required.
  • Ensure that work instructions, QSI’s etc are prepared as per Cook’s Quality System.
  • Ensure that sister company Change Requests are processed and approved in a timely manner.
  • Develop component and product drawings required by sister Company change requests.
  • Complete Supplier Change Notifications as required and support Material Review Board process.
  • Provide Technical input and support for the investigation and resolution of Non Conformances associated with processes by completing NC assessments and investigations.
  • Ensure that all work is carried out according to Company procedures, and that a high level of productivity and quality is achieved and maintained.
  • Responsible for the setup and support of production equipment.
  • Work closely with the Machine Shop to develop jigs, fixtures and tooling to improve production efficiencies.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Formal Production/Engineering/Science qualification preferably and/or relevant manufacturing experience (medical devices, plastics, etc.)
  • Good communication and inter-personal skills.
  • Knowledge of medical device quality standards/practises or similar regulated industry would be an advantage.
  • Good computer skills including knowledge of Microsoft® Office.
  • Proficient in CAD software CREO or similar programs.
  • Must be a good team player who is capable of working well to tight deadlines.
  • High degree of self-motivation.
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Senior Regulatory Affairs Specialist

Cook Group

Limerick
30+ days ago
Limerick
30+ days ago

The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.

 

Function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.

 

Reporting to:               Regulatory Affairs Manager


  • Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
  • Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
  • Maintains an excellent understanding of the global medical device regulations.
  • Maintains a thorough understanding of the products assigned to the team.
  • Works to improve the function of the Regulatory Affairs Department.
  • Understands the progress of the RA team on assigned tasks, and removes roadblocks.
  • Provides support to the RA team members to complete assigned tasks.
  • Mentors and trains new RA team members.
  • Highlights any updates to regulatory requirements to regulatory management.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
  • Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets.
  • Ensures the biocompatibility requirements of the product are adequately addressed.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
  • Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
  • Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
  • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.

  • Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
  • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required.
  • Knowledge of requirements in other jurisdictions where required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft®
  • Proven organisational skills.
  • High self-motivation.
  • Approved External Auditor.
  • Willingness and availability to travel on company business.

Posted

18 days ago

Description

Overview

Design, development and taking to market of medical devices for one or more Cook Medical Strategic Business Units.

 

 

Reporting to: Senior Research & Development Engineer/Research & Development Manager  

 

 

 

Find out more about Cook Medical here

Responsibilities

  • Perform Duties of Research & Development Engineer including:
    • Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
    • Product testing and evaluation, completion of test reports to support design selection.
    • Preparation and presentation of design reviews.
    • Product and project risk analysis and risk management.
    • Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
    • Source new materials components and equipment.
    • Development of component specifications, inspection methods, bills of materials and manufacturing processes.
    • Introduction of new equipment, materials and technologies.

 

  • Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.

 

 

  • Project lead for assigned research & development projects including technical and project management responsibly.
    • Manage and drive project tasks to ensure timely completion of project milestones.
    • Work closely with cross functional groups to achieve project and company goals.
    • Product performance evaluations.
    • Contribute to innovation and creativity within team through filing of disclosures and patents.
    • Hold regular project meetings and document minutes and actions.
    • Ensure project milestones are achieved to meet business metrics.

 

 

 

  • Compliance with Quality, Regulatory and company policies and systems.
  • Communications:
    • Regular communication to cross-functional teams, senior management and business unit leaders.
    • Project status communications and reporting.
  • Remain on the forefront of emerging industry practice

 

 

  • Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
  • Support other cross functional groups to deliver company goals.#
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

 

Qualifications

  • Third level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
  • 2 Years design experience medical device roles.
  • Project planning skills.
  • Execution of project in a timely effective manner.
  • Knowledge of anatomy and physiology.
  • Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Manufacturing design and process understanding.
  • Good working knowledge of Solidworks and/or Pro Engineer CAD.
  • Strong technical writer.
  • Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745.
  • Team Player with ability to develop strong working relationships.
  • Strong communication and inter-personal skills.
  • Good problem solving skills.
  • Highly motivated individual, self-starter with a passion for excellence.
  • Must be able to work in a fast paced environment.
  • Willingness and availability to travel on company business.

 

 

 

Source: Cook Group