Engineering Program Director
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Overview
Job Description
Qualifications:
Bachelor or Master degree in Engineering or related field with 10+ years of experience in medical device development or contract manufacturing.
Direct experience taking a product from concept to commercialization including design controls, verification, validation, and manufacturing readiness.
Direct experience authoring, co-authoring, or substantially supporting 510(k) submissions in partnership with regulatory and quality teams.
Experience interfacing directly with customers in a CDMO or contract manufacturing environment managing multiple concurrent programs.
Strong understanding of regulatory and quality systems including ISO 13485, ISO 14971, and FDA design control requirements.
Experience building or scaling engineering and program management processes across global, cross-functional teams.
PMP or equivalent program management certification is preferred.
Responsibilities:
Lead multiple concurrent customer programs spanning design, development, validation, manufacturing transfer, and commercialization.
Serve as the primary executive interface for customers to ensure alignment on scope, timelines, risk, deliverables, and financial performance.
Lead, manage, and mentor engineering teams and program leaders to strengthen technical capability and execution discipline.
Drive cross-functional execution and process development across engineering, quality, regulatory, supply chain, and global operations teams.
Identify and mitigate technical, operational, and regulatory risks while establishing integrated program plans and resource allocation.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
