Restorative Neurotechnologies
Technology for Cognition
Manufacturing Process Engineer
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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