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 evaluatio