Summary
The Senior Research & Development Engineer will be a highly motivated individual responsible for the product development, study and scientific investigation to support all of Biomimetic Innovations (BMI) and its clients’ products.
Hard working and highly motivated individual, with attention to detail. The candidate must have a background in applicable Science and Engineering and should have excellent communication skills. The ability to work both independently and as part of a team is essential and be self-driven to succeed in all areas. A practical hands-on approach to development activities and problem solving is a must.
Able to work in a dynamic environment with changing priorities. Project and Program Management skills are required.
Role and Responsibilities
- Lead defined BMI development projects including co-development projects with BMI (or PBC Biomed) partners.
- Incorporate relevant design expertise and experience in projects in line with BMI new product pipeline strategy.
- Ensure design solutions meet clinical, usability, performance, and manufacturability requirements.
- Develop and maintain project schedules to track project activities, milestones, and risks in collaboration with Project Management.
- Manage the required project cross-functional resources within define Project Teams to meet defined project deliverable.
- Ensure completion of relevant supporting Design Documentation in compliance with applicable procedures
- Support regulatory submissions (e.g., 510(k), Technical Documentation, Design Dossiers) by providing technical content, justifications, and test evidence.
- Develop and maintain design inputs, outputs, and specifications in accordance with design control requirements.
- Apply risk management activities in line with ISO 14971.
- Work with external suppliers and manufacturing partners to ensure design intent is met.
- Define and execute verification and validation (V&V) strategies, including bench testing, In vivo Studies, and performance evaluations.
- Develop test methods and protocols with lab personnel in accordance with relevant ISO, ASTM, and internal standards.
- Collaborate with Manufacturing, Quality, and Supply Chain teams to support design for manufacturability (DFM) and design transfer activities.
- Actively search for best-in-class technologies among competitors to support the development of BMI’s innovation roadmap
- Mentor and support junior engineers and contribute to technical capability building within the project team.
- Implement structures respecting existing patents; strive for creation of value adding patents each year.
- Support activities related to the maintenance of operational budgets for applicable programs.
- Support grant funding applications as required.
- Keep abreast of developments in the field of bone regeneration through review of current scientific literature, networking within the scientific community and participating at scientific congress.
Qualifications and Education Requirements
- Bachelor’s or Master’s degree in Mechanical engineering, Biomedical Engineering, Materials Engineering, or related discipline.
- 5+ years of R&D experience (Medical device industry/Implantable device experience preferred).
- Strong working knowledge of design controls, risk management, and V&V processes.
- Hands-on experience with mechanical testing, materials, or device-level performance testing.