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