Senior Research & Development Engineer (Vascular - Early Stage Design)

Cook Medical; Limerick; Hybrid; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid Work Model

Company sponsored pension

Medical Health Insurance

Job summary

Cook Medical in Limerick seeks a Senior Research & Development Engineer to lead product development from concept through to market. You will drive design, prototyping, verification, and validation while coordinating across clinicians, KOLs and product managers to deliver innovative vascular devices.

The role requires 5+ years of project leadership, strong technical writing, and expertise in regulatory quality systems. Hybrid work is available, with global collaboration across R&D teams.

Qualifications

• Third level degree in Mechanical, Biomedical, Science, Design or similar discipline; Masters or Ph.D. preferred.
• 5+ years’ experience ideal with proven project leadership abilities.
• Good project management methodology and skills.
• Knowledge of anatomy and physiology and medical device design fundamentals.
• Experience with medical device quality & regulatory systems (ISO13485, FDA CFR 820).

Responsibilities

• Lead design development, prototyping, verification, validation and transfer to production.
• Drive risk analysis, design reviews and design transfer to ensure timely milestones.
• Develop prototypes aligned with clinical and design requirements.
• Collaborate with physicians, KOLs and product managers to innovate devices.
• Mentor and coach team members; manage cross-functional project teams.

Skills

Project Leadership

Project Management

Strong communication

Problem solving

Attention to detail

Self-starter

Team player

Education

Mechanical/Biomedical degree

Tools

SolidWorks

Pro/ENGINEER CAD

MS PowerPoint

Job description

Lead Research & Development team in the design, development and taking to market of medical devices for the Cook Vascular division

Reporting to: Research & Development Manager or Senior Research & Development Manager

Find out more about Cook Medical here

Responsibilities

• Perform Duties of Senior Research & Development Engineer:
  • 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 and effective manner.
  • Product and project risk analysis and risk management.
  • Develop prototypes which are consistent with the clinical and design requirements of the project.
  • Research new therapies and design solutions to develop and complement the existing product portfolio.
  • Introduce 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 team/s including technical and project management leadership responsibly.
  • Lead technical development of projects.
  • Lead all key design decisions to ensure quality design selection.
  • Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
  • Work closely to build effective relationships with cross functional groups to achieve project and company goals.
  • Retrospective project reviews to understand lessons learned.
  • Manage device evaluations.
  • Compliance with Quality, Regulatory and company policies and systems.
• Mentoring, coaching and development of direct reports if required.
  • Foster innovation and creativity within team and perform disclosure reviews.
  • 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.
  • Ensure effective reporting to the R&D Manager or Senior R&D Manager .
• Remain on the forefront of emerging industry practices.
• Instrumental in driving and implementing change to improve departmental and company performance.
• 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.
• Act as a designee of the Research & Development Manager or the Senior Test Engineer if required.
• 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, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
• 5+ years’ experience is ideal.
• Proven Project Leadership abilities.
• Good Project Management methodology and skills.
• Proven track record in delivering quality results in a timely effective manner.
• Knowledge of anatomy and physiology.
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Innovative/Creative Engineer.
• Good manufacturing design and process understanding.
• Good working knowledge of Solidworks and/or Pro Engineer CAD.
• Good presentation skills (working knowledge of MS PowerPoint).
• Strong technical writer.
• Attention to detail and Quality focus.
• Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
• 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.
• Ability to foster relationships with key stakeholders required to ensure on time project delivery.
• Experience of medical device development from concept through to commercialisation.
• Ability to effectively translate needs of clinicians and SBU into project inputs.
• Willingness and availability to travel on company business.

About Cook Limerick

Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets .

Research and Development in Limerick

Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world .

Our R&D team in Limerick is split into two divisions, Vascular and Medsurg . The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch .

The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD ) and venous therapies . The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies.

Our Employee Benefits Include

• Hybrid Work Model
• Company sponsored Defined Contribution pension scheme
• Medical Health Insurance cover for you and your immediate family
• Life Assurance and Income Protection cover
• Educational Assistance
• Performance related Bonus
• 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