Job Title: Product Development Manager
As a seasoned product development professional, you will lead a team of engineers and technicians to bring projects from Phase 1 to commercialization. You will serve as a technical leader for Product Development related improvements and inform development assignments or training related to the PDP procedure.
The ideal candidate will have a degree in mechanical engineering, biomedical engineering, polymer engineering, or other equivalent discipline. You will have 10+ years of work experience in the medical device industry and demonstrated ability to develop medical devices from concept to commercialisation. You will also have experience in design and manufacture of balloon catheters and delivery systems and phase-gated, PDP (Product Development Process) procedure.
Responsibilities:
* Partner with Program Managers to execute the project plan to schedule, meeting or exceeding customer requirements.
* Collaborate with Manufacturing Engineering, NPI Engineering, or SMEs to develop innovative manufacturing processes following lean manufacturing and DFM principles that satisfy customer and regulatory requirements.
* Mentor and develop junior staff members on PDP overview, procedure, and best practices.
* Mentor and develop junior staff members to lead their own projects or sub-portions of larger projects.
* Coordinate and participate in brainstorming and troubleshooting activities.
* Coordinate and participate in design or phase reviews to support the advancement of projects from Phase 1 to commercialisation.
* Participate in design for manufacture/design for assembly activities.
* Participate in customer meetings and visits.
* Familiar with medical device regulations.