Responsibilities:
- Perform Duties of Senior Research & Development Engineer:
- Design and process development:
- Prototyping and test method design.
- Design and process evaluation, reviews, specifications, verification and validation, protocols and reports and 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.
- Generation of Design History File documentation.
- Support of regulatory submissions.
- Design and process development:
- 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, if required.
- Lead technical development of projects.
- Lead 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.
- Communications:
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- 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 R&D Team leader.
- 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 Research & Development Team leader, if required.
Qualifications / Requirements:
- Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
- 7+ years’ experience.
- Proven Project Leadership abilities.
- Experience in DOE and/or Gage R&R is preferred.
- Strong statistical understanding and experience, including good working knowledge of Excel and/or Minitab.
- 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, EU Medical Device Regulation 2017/745, (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 business division into project inputs.
- Willingness and availability to travel on company business.
This role can be remote with one day onsite per week .
