Program Manager - Medical Device

Freudenberg Medical; Beverly (MA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

401K Match

Diversity & Inclusion

Sustainability & Social Commitment

Corporate Events

Personal Development

Job summary

Freudenberg Medical seeks an experienced project/program leader to drive complex medical device programs from concept through launch. You will coordinate cross-functional teams, manage budgets, and ensure regulatory alignment with ISO standards and GMP guidelines.

The role requires deep experience in manufacturing settings and a proven track record in delivering high-quality, compliant products. Based in Beverly, MA (On-Site), you will mentor engineers, manage multiple projects, and liaise with

Qualifications

• Bachelor’s degree in engineering or sciences required.
• 8+ years in Medical Device or related industry.
• 6+ years in Project/Program Management in manufacturing.
• Experience with silicone materials, plastics, and extrusion.
• Strong understanding of ISO standards and GMP in medical device manufacturing.
• Lean/Six Sigma experience and DOE knowledge.
• Willingness to travel to other sites as needed.

Responsibilities

• Direct cross-functional teams, manage resources and deliverables.
• Drive all phases of the product development cycle from feasibility to launch.
• Develop budgets and transfer cost of goods sold; communicate variances to stakeholders.
• Maintain alignment with clinicians, customers and internal teams.
• Identify constraints and maintain schedules with mitigations.
• Measure KPIs and drive cost reductions through process optimization.
• Maintain compliant design/process documentation for regulatory readiness.
• Mentor engineering staff and foster a high-performing project culture.

Skills

Project management

Leadership

Cross-functional collaboration

Budgeting

Regulatory compliance

ISO 13485

Lean Six Sigma

Design of Experiments

Risk management

Mentoring

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Job description

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high‑quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

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.

*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time‑off. Additional details will be shared during the recruitment process.

Locations: Beverly, MA and Baldwin Park, CA (On‑Site). Freudenberg Medical LLC.

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

Responsibilities

• Direct cross‑functional internal teams, external vendors, suppliers, and strategic partners; assess resource needs, utilization, and development. May 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.
• Oversee multiple related projects or a full customer program with business‑level accountability, using Program Management best practices through entire corporate PDP.
• Managing efforts for compliance ensure design control, DMR/DHF compliance, risk analysis, and alignment with ISO standards, country‑specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements.
• Provide technical and project‑management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization.
• Evaluate new business opportunities and lead quoting and proposal development and collaborate with Sales to close deals aligned with strategic goals.
• Maintain project documentation in line with internal procedures and notified‑body expectations, supporting audits and ensuring robust change‑control and traceability. Prepare reports and project summaries to communicate the status of projects on a regular basis.

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.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.