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.

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical device manufacturingprocess validationrisk managementFMEAsfailure analysismanufacturing automationclean room assemblypackaginglabelingsterilization

Soft Skills

collaborative supportgoal orientedproductive work environmenttechnical supportproblem solving

Certifications

B.S. in relevant engineering discipline