Freudenberg Nonwovens, LP

Program Manager - Medical Device

Freudenberg Nonwovens, LP • $120K — $140K *
Baldwin Park, CA 91706In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Chemistry, Biology, or a related field.
  • 8+ years in the Medical Device or related industry.
  • 6+ years in Project/Program Management within manufacturing environments.
  • Prior experience with silicone material, plastics, and/or extrusions.
  • In-depth knowledge of medical device production processes and related materials.
  • Advanced skills in engineering/statistical problem solving, including DOE.
  • Deep understanding of ISO standards and GMP principles relevant to medical devices.
  • Experience in managing complex development programs.

Responsibilities

  • Direct cross-functional teams and manage resource allocation and development.
  • Drive the entire product development cycle from feasibility to production.
  • Develop and manage project budgets, communicating financial variances effectively.
  • Maintain communication with key stakeholders and resolve product issues promptly.
  • Identify project constraints, risks, and manage timelines effectively.
  • Measure program KPIs and foster a high-performance culture through process optimization.
  • Develop compliant documentation and oversee quality measures for regulatory readiness.

Benefits

  • Comprehensive training and development opportunities.
  • Mentorship programs to support career advancement.
  • Collaborative culture promoting teamwork and high performance.
  • Support for compliance with industry regulations and standards.
Full Job Description
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.


The expected salary range for this position is $120,000 to $140,000 annually, depending on skills, experience, and qualifications.

Freudenberg Medical LLC

About Freudenberg Nonwovens, LP

Freudenberg Nonwovens is a leading manufacturer of nonwoven fabrics for a variety of industries, including automotive, construction, filtration, healthcare, and hygiene. The company's products are used in a wide range of applications, from air and liquid filtration to wound care and feminine hygiene. Freudenberg Nonwovens is a subsidiary of the Freudenberg Group, a global technology company with operations in more than 60 countries. The company was founded in 1849 and is headquartered in Weinheim, Germany. Freudenberg Nonwovens has manufacturing facilities in North America, Europe, and Asia.
Learn more about Freudenberg Nonwovens, LP
Size
2,000 employees
Industry
Manufacturing & Automotive
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Freudenberg Nonwovens, LP

More Pharmaceuticals & Biotech Jobs

Find similar Program Manager - Medical Device jobs:

NationwideBaldwin Park, CA