Job Opportunity:
We are seeking a highly skilled Product Development Director to lead our team of engineers and technicians in bringing projects from Phase 1 to commercialization.
Key Responsibilities:
* Partner with Program Managers to execute the project plan, meeting customer requirements and optimizing resources.
* Collaborate with Manufacturing Engineering, NPI Engineering, or SMEs to develop innovative manufacturing processes that satisfy customer and regulatory requirements.
* Mentor junior staff members on product development principles, procedure, and best practices.
* Develop junior staff members to lead their own projects or sub-portions of larger projects.
* Facilitate brainstorming and troubleshooting activities.
* Participate in design reviews to support the advancement of projects from Phase 1 to commercialisation.
* Contribute to design for manufacture/design for assembly activities.
* PARTICIPATE IN CUSTOMER MEETINGS AND VISITS.
* Familiar with medical device regulations FDA, QSR and ISO 13485.
Required Skills and Qualifications:
* Degree in mechanical engineering, biomedical engineering, polymer engineering or other equivalent discipline.
* 10+ years work experience in medical device or similar industry is preferred
* Demonstrated ability to develop medical devices from concept to commercialisation.
* Experience in design and manufacture of balloon catheters and delivery systems.
* Experience in phase-gated, PDP (Product Development Process) procedure.