Program Manager - Medical Device

Working at Freudenberg: We will wow your world!

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.

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.

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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.