Sr. Program Manager
$120,000–$150,000 year
On-site · Fairfield, New Jersey, United States
Job Summary
Sr. Program Manager to oversee cross-functional programs from concept through transfer to manufacturing in a medical device/life sciences context. Responsibilities include leading multi-disciplinary teams, coordinating schedules and milestones, design reviews, tooling kickoff, and postmortems; ensuring regulatory (FDA) compliance; applying APQP, DOE, FMEA, process flowcharts, control plans, and Gage R&R; managing BOM creation and ECO processes; coordinating tooling transfer to manufacturing; supplier management; and supporting customer and regulatory/audit activities. Roles involve collaboration with design engineering, tooling, manufacturing, and suppliers to ensure on-time, in-budget program delivery and potential sales opportunities.
Required Qualifications
- Minimum of a bachelor’s degree in mechanical engineering or biomedical engineering
- Minimum of 10 years of medical device or life science industry experience, preferably in a product development engineering position
- Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products
- Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives
- Experience in Regulatory (FDA) requirements and processes for development
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