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.

Engineering Manager - New Product Introduction
Previous experience leading teams and flawless launch of new products to production for medical devices (Silicone/Plastic Injection Molding)

Your tasks

  • Leading a team of engineers, while overseeing the design, development, improvement and validation of tooling, and fixtures in order to meet manufacturability requirements for new and existing products.
  • Partnering with customers, vendors and other key stakeholders, influence the product specifications and design such that corporate business objectives are met or exceeded.
  • Ensure team communicates project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews with core team and senior management.
  • Assign and prioritize engineering resources to ensure projects are running per specifications in terms of product cost and product quality while meeting deadlines.
  • Review and approve protocols, reports, engineering orders, purchase requisitions and quality notifications per the quality system, project requirements and industry standards.
  • Assure the stable manufacturability of new products by overseeing the design, qualification, optimization, and validation of processes and tooling via IQ/OQ/PQ, gauge R&R studies, and process capability studies 
  • Enable growth and development of NPI team by establishing opportunities for knowledge sharing; training; coaching and mentoring, and to deliver excellence to every internal and external customer
  • Establish clear measurable goals and objectives by which to determine individual and team results utilizing talent Management process (i.e. operational metrics, results against project timelines, training documentation, knowledge of operational roles and responsibilities, personal development goals).
  • Support and enforce company goals and objectives, policies and procedures regarding Safety, Health and Environmental, Good Manufacturing Practices, Good Documentation Practices, FDA and ISO regulations.

Our expectations

  • Bachelor’s degree in a related technical field such as Mechanical Engineering or Plastics Engineering
  • 5+ years experience in a manufacturing engineering environment supervising and developing others.
  • 3+ years experience in managing engineering resources including:  tooling, process, project, and design resources.
  • 2+ years experience in a regulated industry; medical device preferred.
  • Working knowledge of silicone injection molding processes
  • Solid knowledge of GMP, ISO regulations. 
  • Strong applied knowledge with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Computer literate with knowledge of spreadsheet and word processing packages, and SolidWorks.
  • Green Belt certification in Lean or Six Sigma desired.
  • Drives team with performance metrics in accordance to business strategies and goals.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to manage risks and make business decisions

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: Beverly, MA 01915

We are currently hiring for an Engineering Manager - New Product Introduction (NPI) who is:

  • Driven and focused with a positive attitude on design transfer, validation, and the flawless launch of new products into production for medical devices.
  • Responsible to will lead the development for new programs and improvements to current products through the development, management and balancing of engineering resources, leveraging existing technologies and evaluating new technologies to meet or exceed strategic goals.  
  • Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.

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 ∙
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