Responsibilities:
- Perform Duties of 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 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.
- Development of the Design History File
- 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 practices.
- 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.
Qualifications / Requirements:
- Third level degree in Mechanical, Biomedical, Science, Design or similar discipline.
- 2+ years’ design experience in 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.
This role can be remote with one day a week onsite .
