Senior Product Development Engineer
Summary of the role
You will participate as a team member in the product development process from concept to commercialization of novel medical devices. As Senior Product Development Engineer you will act as a technical leader for projects and may be assigned engineers, technician, interns or operators to supervise and/or provide guidance. You will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
Role and Responsibilities
- Technical leader on PDP projects leading product and process development activities from concept to commercialization.
- Develop new concepts, prototypes and products from concept to commercialization following the PDP procedure meeting or exceeding customer requirements.
- Partner with Program Managers to generate project plans and execute the project plan to schedule, within budget constraints, meeting customer requirements.
- Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
- Co-ordinate and participate in brainstorming and troubleshooting activities.
- Co-ordinate and participate in design reviews to support advancement of projects from concept to commercialization following the PDP procedure.
- Co-ordinate and participate in design for manufacture/design for assembly activities.
- Co-ordinate and participate in the organization and execution of interdepartmental activities to ensure advancement of projects from concept to commercialization following
- procedures.
- Maintains detailed documentation throughout all project phases.
- Co-ordinate and participate in design and process verification and validation activities working with manufacturing and quality personnel.
- Work with other sites to support design and development activities.
- Co-ordinate and participate in customer meetings and visits.
- Familiar with medical device regulations FDA, QSR and ISO 13485.
Skills and Qualifications
- Degree in mechanical engineering, biomedical engineering, polymer engineering or other equivalent discipline.
- 5+ years’ work experience in medical device or similar industry.
- Demonstrated ability to develop medical devices from concept to commercialization.
- Experience in design and manufacture of balloon catheters and delivery systems.
- Experience in phase-gated, PDP (Product Development Process) procedure.
- Familiar with DFM/DFA principles.
- Strong communication and presentation skills.
- Strong problem solving and analytical skills.
