medical device development research and development validation prototype R&D design design verification test method design
5 - 6 Years
Third Level Degree
Senior Product Development Engineer
In partnership with its client, Kenny-Whelan is currently seeking a Senior Product Development Engineer to work for their client in the Limerick area. This position reports to the Director of Engineering, you will lead the product development team in the design, development and taking to market of medical devices.
- Perform Duties of Senior Product 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 effective manner.
- Product and project risk analysis and risk management.
- Developing 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.
- 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 product 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 and drive project tasks to ensure timely completion of project milestones.
- Work closely with cross functional groups to achieve project and company goals.
- Retrospective project reviews to understand lessons learned.
- Manage device evaluations.
- Team Management:
- Mentoring, coaching and development of direct reports
- Performance of routine appraisals to deliver best results and to obtain the maximum team performance.
- Foster innovation and creativity within team and perform disclosure reviews.
- Manage the activities of the product development team and to hold regular team meetings.
- Drive team to ensure business metrics are achieved
- Compliance with Quality, Regulatory and company policies and systems.
- Regular communication to cross-functional teams, senior management and business unit leaders.
- Project status communications and reporting.
- 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 Director of Engineering.
Skills, Abilities and Education:
- Third level degree in Mechanical, Biomedical or similar discipline.
- 5 Years design experience preferable in a senior medical device role.
- 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.
If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: email@example.com or telephone for a confidential chat on 021-4665407