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 followingprocedures.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.
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