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.

 

Manufacturing Engineer II
Provide technical knowledge in new product launch into manufacturing

Your tasks

  • Work collaboratively with engineers and customer personnel to design and develop silicone extrusion and molding processes using existing and innovative technologies.
  • Develop process validation protocols and reports, in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
  • Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
  • Create bills of materials, manufacturing procedures, and routers for components, assemblies, packaging, labeling, and other documents needed for the device master record.
  • Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
  • Work with internal resources to obtain and plan for the installation of equipment in a clean environment.  Create and execute Installation Qualification protocols and reports.
  • Design or aid in the design/modification of extrusion and molding processing tooling.
  • Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
  • Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost. Create DOEs to characterize and improve processes.
  • Investigate and/or create EO (Engineering Change Orders), disposition material, develop and implement process changes and proper documentation of any such changes.
  • Attend daily meetings to provide communication and technical support to meet daily production requirements and NPI project timelines.
  • Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and Six Sigma skills.

 

Teamwork

  • Represent process development engineering in communications with customers and suppliers.
  • Participate or lead as a member of a project team in support of multiple process development projects.  
  • Be responsible for meeting overall project deliverables and objectives.
  • Incorporate Critical Path Project Management into your daily work habits.
  • Assist in the creation and maintenance of credible project schedules by:
    • Providing accurate estimates of work required to complete project tasks.
    • Ensuring that project task links and durations are accurate and up to date.
    • Completing project tasks within the estimated durations.
    • Working with the project team to identify ways to address potential project delays.

Our expectations

  • Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering. EIT or PE a plus.
  • Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment.
  • Must possess a hands-on mechanical aptitude.
  • Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
  • Ability to provide accurate inputs for the preparation of project timelines and estimates.
  • Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint. Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings. Able to learn and use MRP systems; SAP preferred.
  • Ability to utilize metrology equipment such as pin gauges, calipers, micrometers. CMMs.
  • Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis, DMAIC, 8D, 5-whys. 
  • Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.
  • Ability to work with little supervision; to work in teams or independently.

 

Preferred Qualifications:

  • Medical manufacturing experience.
  • Experience in silicone, plastic, or rubber extrusion or molding manufacturing.
  • Experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent. 

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 Manufacturing Engineer II who:

  • Will identify, develop, and qualify new manufacturing processes, fixturing, and tooling in preparation of transfer to manufacturing for commercial production
  • Enjoys working independently and in a team environment where quality in manufacturing is key.
  • Is detail oriented and motivated to learn quickly and provide support for existing production processes, initiate continuous improvement activities, and will implement, troubleshoot, and optimize setups to meet engineering and customer requirements.
  • 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 ∙ 92 Blackburn Center ∙ 01931 Gloucester, MA ∙ www.freudenbergmedical.com
Print Apply