Program Manager - Medical Device

About the role

Support our team as Program Manager - Medical Device. Responsibilities include:

• Direct cross-functional internal teams, external vendors, suppliers, and strategic partners;
• Assess resource needs, utilization, and development;
• Manage direct reports;
• Build team ownership and commitment to projects and assign clear authority, accountability, and deliverables;
• Drive all phases of the product development cycle, including feasibility, concept, validation, production transfer, and sustaining manufacturing;
• Guide specification development, tooling, and test methodologies;
• Develop and monitor project budgets, internal billing, and transfer cost of goods sold (TCOGS);
• Communicate financial variances and negotiate adjustments with customers and stakeholders;
• Maintain alignment with clinicians, customers, internal teams, and FM key stakeholders through timely updates, product deliverables, issue resolution, and structured project communications;
• Identify constraints and risks, maintain credible schedules, align with CCPM/PCE practices, and ensure communication of updates to project timelines and along with any mitigation strategies;
• Measure, report and improve program KPIs, demonstrate cost reduction through process optimization, and encourage positive behaviors and teamwork norms for high-performance culture;
• Develop and maintain compliant design/process documentation; oversee test and measurement fixture identification and ensure quality documentation for regulatory and operational readiness;
• Mentor and support engineering staff development while fostering a high-performing, collaborative project culture.

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field;
• 8+ years’ experience in Medical Device or related industry;
• 6+ years’ experience in Project/Program Management in a manufacturing environment, with advanced experience of leading work within a project plan framework, including managing a schedule, budget, scope, progress, reporting, and prototyping through product launch;
• Prior experience with silicone material, plastics, and/or extrusions;
• In-depth understanding of engineering and manufacturing processes used in medical device production, such as engineering drawings, running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used;
• Advanced experience with engineering/statistical problem-solving methodologies (including Design of Experiments [DOE]), critical thinking, and deductive skills;
• Deep understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971;
• Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States), and CE design controls for product development;
• Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects;
• Demonstrated experience providing leadership and managing full development programs or multiple projects of high complexity;
• May manage team members, train new team members and provide input to employee performance evaluations;
• Advanced degree or MBA preferred;
• Understanding of program management best practices and entire product life cycle;
• Travel to other sites as needed for projects.

Benefits

• 401K Match: Save for retirement with the company's help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Pay

The expected salary range for this position is $120,000 to $140,000 annually, depending on skills, experience, and qualifications.