Freudenberg Medical · 1 day ago
Project Manager
Minnetonka, MN
Full-time
Onsite
Mid, Senior Level
$85K/yr - $115K/yr
3+ years expFreudenberg Medical is a global technology group committed to making the world cleaner, healthier, and more comfortable. They are seeking a Project Manager to lead the development of manufacturing cost models, track project metrics, and ensure compliance with regulatory standards in the medical device industry.
ManufacturingMedical Device
No H1B
Responsibilities
Lead development of accurate manufacturing cost models, make-vs-buy decisions, work-center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives
Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous-improvement and Lean/Six Sigma activities to boost quality, delivery, and cost
Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data-driven recommendations to stakeholders
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
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
Manages a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements
Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs
Qualification
Required
Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field
3+ years' experience in Medical Device or related industry
2+ years' experience in leading teams in a manufacturing or engineering environment, with demonstrated experience of managing work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting
Understanding of scientific principles and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, and 45001. 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 EU MDR)
Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects
Demonstrated experience providing leadership and managing multiple projects of low to medium complexity
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.
Personal Development: We offer a variety of trainings to ensure you can develop in your career.
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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