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 ...