Restorative Neurotechnologies

Technology for Cognition

Manufacturing Process Engineer

EngineerEngineerFull TimeRemoteTeam 11-50Since 2018H1B No SponsorCompany SiteLinkedIn

Location

Minnesota

Posted

16 days ago

Salary

$150K - $200K / year

Bachelor Degree10 yrs expEnglishAssembly

Job Description

• Primary contact for technical support to Ensure Echo’s suppliers succeed in delivering products and services critical to Echo’s success. • Provide input and collaborative support to the product development process ensuring that design outputs are well defined, manufacturable, and consistent with medical device quality system requirements. • Work with suppliers and Echo’s development team to ensure that suppliers appropriately implement specifications for components, assemblies, and finished devices consistent with design intent and quality system requirements. • Develop documentation that accurately maps Echo’s designs into supplier’s processes. • Participate in risk management activities including Process FMEAs, Validation, and failure analysis. • Continuously improve supply chain related processes with an eye toward adding value & improving efficiency. • Maintain a goal oriented, collaborative & productive work environment. • Ensure product is manufactured in compliance with Echo’s quality system, FDA and EU Requirements. Reconcile any conflicts between Echo’s quality system and suppliers. • Provide technical support to resolve non-conformance and corrective actions with suppliers.

Job Requirements

  • B.S. in relevant engineering discipline, or equivalent experience.
  • 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
  • Experience with active implantable systems (Implant, Leads, Externals, etc.).
  • Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
  • Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
  • Experience with manufacturing automation.
  • Experience in defining and executing process validation activities.
  • Experience collaborating with internal customers and external partners.
  • Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
  • Experience with Solidworks, Labview / manufacturing process and test automation software.

Benefits

  • Competitive compensation, including stock options.
  • Comprehensive benefits package.
  • 401(k) program with matching contributions.

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