The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

 

Project Manager – Injection Molding
Customer focused project launch leader to drive cross functional teams

Your tasks

  • Provides leadership to manage multiple projects and production launches using established Advanced Product Quality Planning (APQP) project management practices and MS Project.
  • Leads cross-functional teams of resources, drawing from other functional areas, to ensure on-time delivery and a flawless launch to production utilizing ARAS and APQP best-practices.
  • Provides leadership to comply with, and maintains documentation in accordance with Freudenberg Medical Quality System Requirements (QSR), FDA cGMP, internal procedures, customer requirements and notified body requirements.
  • Measures, reports, and continuously improves performance metrics (KPIs) of the product development and launch process.
  • Assists in development of design standards, cost standards and pricing standards to expedite and provide input for continuous improvement of the quote process
  • Develop accurate and timely manufacturing costs in response to customer or internal inquiries; create new work center costs as needed for cost calculations.
  • Responsible to support new product cost-estimating and team feasibility reviews for new business opportunities for molding in addition to large scale sustaining projects.
  • Reviews, recommends, and directs the “make or buy” decision process.
  • Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
  • Maintains adherence to Company policies, safety/ergonomic standards and good housekeeping practices

Our expectations

  • Bachelor’s degree in a related technical field such as Mechanical Engineering, Plastics or Medical Engineering preferred.
  • PMP Certification in Project Management and APICS certification
  • 5 years minimum of related experience in a regulated manufacturing environment, preferably medical or healthcare products in an engineering role.
  • 2 years minimum Project management experience in a manufacturing environment utilizing injection molding methods
  • Demonstrated experience providing leadership and managing multiple projects of medium complexity
  • Working knowledge of ISO-13485 and FDA cGMP regulations
  • Working knowledge of engineering terminology, injection molding processes, tooling and validation protocols.
  • Working knowledge of work centers, cost structure, and basic industrial engineering practices.
  • Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers

Preferred Qualifications:

  • Lean Systems or Six-Sigma Green Belt Certification Preferred
  • Strong business and economic acumen
  • Prefer experience using SAP software and prior experience in a product cost-estimating role for molding.

Freudenberg Medical is a global leader in medical contract manufacturing; we offer the following services for medical device, pharmaceutical and IVD clients worldwide − product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms.

Location: Carpinteria, CA

We are currently hiring for a Project Manager- Molding who is:

  • Responsible for managing new prototype development projects, and also new production launches focused on silicone injection molding and special projects using established Advanced Product Quality Planning (APQP) project management practices. 
  • Hands-on in a dynamic manufacturing environment where everyone is challenged by rolling up their sleeves to develop and implement solutions for our customer.
  • Be the face of the company through interactions with customers, suppliers and vendors to present technical solutions with a focus on quality products.
  • Self-motivated and thrives in a fast –paced, cutting-edge, “lean” systems environment, where priorities can often change on a daily basis.

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.

Do you have any questions?

Freudenberg Medical
Rachel Peterson ∙ Human Resources ∙ 1110 Mark Ave ∙ 93013 Carpinteria, CA ∙ www.freudenbergmedical.com
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