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.

Engineer I
Location: 5050 Rivergrade Road, Baldwin Park, California 91706

Your tasks

  • Responsible for collaborating with project managers to gather and prepare all documentation relevant to an assigned project; draft, issue, and implement validation protocols and production documents utilizing information provided by customers and project managers;
  • Gather customer and technical information to make changes to documents or procedures at the customer’s request;
  • Develop engineering quotations, make decisions on pricing, specifications and standards, and communicate with suppliers and/or customers as needed;
  • Collaborate with Document Control to ensure documentations are compliant to company quality system, and create/update bills of material and recipe in ERP system per customer requirements;
  • Support production team members and validation coordinators;
  • Perform quote engineering, validations, and mold trial runs as needed per engineering principles;
  • Utilize SolidWorks, Minitab, ISO 13485:2003/2016 standards and Microsoft suite of products including Word, Excel, Project, Access, and Visio perform duties;
  • Provide instructions to metrology inspections, analyze metrology results and perform statistical analysis for validations, process control and troubleshooting activities;
  • Draft and issue validation deviations, engineering change controls, and other reports for optimal efficiency;
  • Responsible for blueprint and schematics reading; support sustaining engineering in cGMP production environment;
  • Provide inputs to quoting team for any new projects or modifications to existing quotes;
  • Work with quality team to investigate assigned complaints and CAPAs;
  • Support operations and project manager with customer communication regarding action item deliveries and project schedules;
  • Maintain customer relationships;
  • Participate and support lean initiatives.

Our expectations

Education: Master’s Degree – Mechanical Engineering, Chemical and Biomedical Engineering, or in a related field of study (will accept equivalent foreign degree).

Training: None

Experience: One (1) year in the position above, as an Engineering Intern, as an Engineer, or in a related occupation;

Other Requirements: Experience must include one (1) years use of the following: SolidWorks, Minitab, and Microsoft suite of products including Excel, Project, Access, and Visio; blueprint and schematics reading, ISO 13485:2003/2016 standards and cGMP production environment.

Will also accept any suitable combination of education, training, and/or experience.

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. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Costa Rica, Europe and Asia.

Location: 5050 Rivergrade Road, Baldwin Park, California 91706

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
Rechelle Mendez ∙ HR ∙ 92 Blackburn Center ∙ 01931 Gloucester, MA ∙ www.freudenbergmedical.com
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