Senior Program Manager - Medical Devices

Freudenberg Medical LLC; Minnetonka (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

Freudenberg Medical LLC is seeking an experienced Program Manager to drive complex medical device programs from concept through manufacturing transfer. You will lead cross-functional teams, manage budgets and schedules, and coordinate external partners to ensure milestones are met.

The role requires a BS in engineering and 6–10 years of program management experience in medical devices, with strong technical writing and proven leadership abilities.

Qualifications

• Bachelor of Science engineering degree and medical device experience are required.
• 6–10 years’ experience as a program manager in a manufacturing medical device company.
• Proven track record leading large complex programs with external and internal customers.
• Technical product development experience in design, process, or quality engineering.
• Working knowledge of MDR, FDA, and CE design controls.

Responsibilities

• Provide leadership, goal-setting, communications, and facilitation to guide project personnel in a matrixed environment.
• Lead project teams on concepts, design and process development, transfers, and manufacturing transfers.
• Manage external contractors and vendors to meet milestones and budgets.
• Track and manage project schedules and budgets to plan.
• Identify deviations and manage project risk with client and Freudenberg Medical.
• Coordinate resource allocations and monitor utilization/efficiency.
• Oversee monthly billing and revenue estimates; develop transfer costs of goods sold.
• Communicate with clients regularly and provide monthly updates to management.
• Document meetings and ensure timely resolution of issues and deviations.

Skills

Project management

Leadership

Communication

Technical writing

Lean tools

Education

Bachelor of Science engineering degree, BSME or BSBME (or related discipline)

Tools

Microsoft Project

Excel

Word

PowerPoint

Job description

Working at Freudenberg: We will wow your world!

Responsibilities

Provide leadership, goal-setting, communications, and facilitation skills to guide and motivate project personnel in a matrixed environment.

Be able to lead project teams on a variety of complex projects such as concept development, design and process development, design transfers, and manufacturing transfers.

Manage external contractors and vendors to ensure completion of projects per the agreed upon milestones and within budget.

Responsible for tracking, monitoring and managing project schedules.

Track and manage project budget to plan and identify and improve processes to reduce costs.

Identify and manage resolution of potential deviations from the quote/contract, Project Master Plan or other project documents along with performing and managing project risk relative to the client and Freudenberg Medical.

Identify and recommend appropriate resource allocations from all areas to support the project requirements and monitor their utilization/efficiency.

Manage billing/invoicing activities on a monthly basis and provide monthly revenue estimates.

Work with manufacturing team to develop the transfer cost of goods sold (TCOGS).

Communicate with clients on a regular basis (as required) and provide monthly updates to Freudenberg Medical Management.

Document project and team meetings minutes and distribute to appropriate management.

Ensure client issues/deviations are resolved and documented in a timely manner.

Communicate variances in project budgets, plans and schedules with clients, Business Development and Management.

Negotiate necessary changes with clients.

Assist Business Development to evaluate new business opportunities along with coordinating/developing quotes to close deals.

Support contract development for product development and manufacturing projects.

Coach and mentor Product Development Staff, providing feedback to managers and supervisors as needed.

Qualifications

Bachelor of Science engineering degree, BSME or BSBME (or related discipline) and experience in the medical device field.

6 - 10 years’ experience in a program manager position for a manufacturing company in medical device industry.

Demonstrated experience leading large complex programs with external and internal customers.

Technical product development experience, e.g. design, process, or quality engineering.

Working knowledge of MDR, FDA, and CE design controls.

Strong technical writing ability.

Leadership ability and organizational skills.

Strong team oriented professional with good interpersonal skills who is hands‑on with a high energy approach to work.

Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.

Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates.

Execute tasks in a timely manner without direct supervision.

Thorough understanding and working knowledge of ISO13485.

Ability to prioritize tasks.

Applies decision making & analysis tools to align stakeholders, document rationale and achieve optimum outcomes.

Embedded utilization of Lean tools as necessary for new programs and continuous improvement.

Equal Opportunity Employer

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.

Freudenberg Medical LLC Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.