Senior Medical Device Program Manager – Regulatory

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

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