Job Title:
Product Development Manager
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Job Overview:
The Product Development Manager will lead a team of engineers and technicians to successfully transition projects from initial development to commercialization.
Key Responsibilities:
* Collaborate with cross-functional teams, including Program Managers, to ensure project plans are executed on schedule, within allocated resources, and meeting or exceeding customer requirements.
* Work closely with Manufacturing Engineering, NPI Engineering, and subject matter experts to develop innovative manufacturing processes that adhere to lean manufacturing and DFM principles, ensuring compliance with regulatory and customer requirements as well as metrics such as yield, cost, and delivery performance.
* Mentor junior staff in PDP best practices, procedures, and overview.
* Guide junior staff to lead their own projects or portions of larger initiatives.
* Participate in brainstorming sessions and troubleshoot activities.
* Support project progression through design reviews and phase gates from initial development to commercialization, following established procedures.
* Engage in design for manufacture and assembly activities.
* Attend customer meetings and site visits.
* Ensure familiarity with medical device regulations, including FDA, QSR, and ISO 13485 standards.
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Requirements:
Qualifications:
* Degree in mechanical engineering, biomedical engineering, polymer engineering, or a related field.
* At least 10 years of experience in the medical device industry or similar field.
* Proven ability to develop medical devices from concept to commercialization.
* Experience with design and manufacture of balloon catheters and delivery systems.
* Familiarity with phase-gated product development procedures.