Freudenberg Medical · 1 day ago
Program Manager
Beverly, MA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $150K/yr
8+ years expFreudenberg Medical is a trusted Contract Manufacturing Organization that delivers high-quality solutions for medical device and pharmaceutical companies. The Program Manager will oversee cross-functional teams, manage product development cycles, and ensure compliance with regulatory standards while driving project success and fostering a collaborative culture.
ManufacturingMedical Device
No H1B
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
Oversees 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
Develop and maintain compliant design/process documentation; oversee test and measurement fixture identification and ensure quality documentation for regulatory and operational readiness
Qualification
Required
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
Understanding of program management best practices and entire product life cycle
Preferred
Advanced degree or MBA preferred
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.
Personal Development: We offer a variety of trainings to ensure you can develop in your career.
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.
Company
Freudenberg Medical
A global developer and manufacturer of specialty components and minimally invasive device solutions
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Kurt Ziminski
CFO
Michael P. McGee
Chief Operating Officer
Recent News
2025-12-06
Medical Product Outsourcing
2025-09-26
2025-09-25
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