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Job Description
Product Development Engineer role involves leading product development from concept to commercialization of novel medical devices.
You will participate as a team member in the product development process, act as a technical leader for projects, and supervise engineers, technicians, interns, or operators.
As a Senior Product Development Engineer, you will work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
Responsibilities
- Lead product and process development activities from concept to commercialization.
- Develop new concepts, prototypes, and products that meet customer requirements.
- Partner with Program Managers to generate project plans and execute them on schedule and within budget.
- Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
- Coordinate and participate in brainstorming and troubleshooting activities.
- Coordinate and participate in design reviews to support advancement of projects.
- Coordinate and participate in design for manufacture/design for assembly activities.
- Coordinate and participate in interdepartmental activities to ensure advancement of projects.
- Maintain detailed documentation throughout all project phases.
- Coordinate and participate in design and process verification and validation activities.
- Work with other sites to support design and development activities.
- Coordinate and participate in customer meetings and visits.
Requirements
- Degree in mechanical engineering, biomedical engineering, polymer engineering, or equivalent discipline.
- 3-5 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 procedure.
- Familiar with DFM/DFA principles.
- Strong communication and presentation skills.
- Strong problem-solving and analytical skills.