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Job Description
Structured overview of role & requirementsAbout This Role
Lead and motivate a cross-functional, hybrid agile team to deliver compliance, supply continuity, and quality projects for a blood specimen collection product group.
Plan and prioritize sprint tasks in alignment with organizational goals, regulatory requirements, and impact dates to optimize value delivery.
Ensure adherence to phase-gate processes and completion of all relevant Design History File and Change Control documentation.
Minimum Requirements
Bachelor's degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering, or closely related engineering field.
Overall experience of 10+ years with at least 8 years in product development/design; minimum 5 years in project management.
Experience in medical device industries within FDA or other regulated environments is mandatory.
Program Management Professional Certificate preferred but not mandatory.
Ideal Candidate Profile
Experienced in leading hybrid agile project teams with strong knowledge of agile methodologies in regulated medical device environments.
Demonstrated capability in managing Class II medical device development, including design change activities and process control documentation.
Strong analytical and problem-solving skills with proven ability to clarify ambiguous situations and make sound business decisions based on diverse data inputs.