Senior Research And Development Engineer - Early Stage Design

HERO Recruitment; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

HERO Recruitment seeks a Senior Research & Development Engineer (Vascular - Early Stage Design) to lead the design and development of innovative medical devices, ensuring compliance with quality and regulatory standards, and mentoring team members to foster a culture of innovation.

The role involves design development, prototyping, testing, risk management, and cross-functional collaboration with clinicians and product managers to advance the portfolio and bring new devices to market.

Qualifications

• Third level degree in Mechanical, Biomedical, Science, Design or similar; Masters/Ph.D. preferred but not essential.
• Minimum of 5 years' experience in a relevant role.
• Proven project leadership abilities with a track record of delivering results.
• Strong knowledge of medical device design and applicable quality/regulatory standards (ISO13485, FDA CFR 820).
• Proficient in SolidWorks and/or Pro/Engineer CAD.

Responsibilities

• Lead design development, prototyping, test method design, design evaluation, design reviews, and transfer to production activities.
• Perform product and project risk analyses and manage risk.
• Develop prototypes aligned with clinical and design requirements.
• Research new therapies and design solutions to broaden the product portfolio.
• Collaborate with KOLs, physicians, and product managers to advance medical devices.
• Lead technical development and key design decisions; ensure timely milestones.
• Mentor and develop direct reports and foster a culture of innovation.
• Ensure compliance with Quality, Regulatory, and company policies.

Skills

Project leadership

Project management

Communication skills

Team collaboration

Problem solving

Attention to detail

Self-starter

Fast-paced work environment

Clinical translation

Education

Mechanical/Biomedical degree

5+ years experience

Tools

SolidWorks

Pro/Engineer CAD

Job description

The Senior Research & Development Engineer (Vascular - Early Stage Design) will be responsible for leading the design and development of innovative medical devices, ensuring compliance with quality and regulatory standards, and mentoring team members to foster a culture of innovation.

Responsibilities

• 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 & 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.