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Averro · 5 days ago

Senior Sustaining Engineer

Middleton, WI

Full-time

Onsite

Senior Level

$130K/yr - $130K/yr

5+ years exp

Averro is a Veteran-Owned organization dedicated to delivering innovative talent solutions and technology services. They are seeking a Senior Sustaining Engineer to oversee medical devices across the full product lifecycle, leading technical and product sustaining issues while ensuring compliance and continuous improvement.

Internet

Responsibilities

Responsible for all technical and product sustaining issues

Leads sustaining design changes, component obsolescence issues, yield performance, and supporting regulatory compliance

Change product design to meet mechanical and electrical changes

Support all product design-related matters related to released manufactured products and purchased components

Perform root cause analyses, resolve issues, implement product and manufacturing process changes, modifications, and design enhancements

Investigate and resolve technical issues via corrective and preventative actions- leveraging appropriate problem-solving techniques

Support the implementation and maintenance of processes utilized in internal and external manufacturing, and depot repair and field service activities

Respond to production stoppages due to supplier, process, or quality- related matters

Drive continuous improvement and Value Engineering initiatives on released product

Provide engineering support for product compliance and safety testing

Support the design and testing of new products by providing effective Design for Manufacturing / Design for Test guidance

Deliver medical device design documentation compliant with FDA design controls, good documentation practices, ISO 9001, and ISO 13485

Qualification

Mechanical design engineeringSustaining product designMedical device manufacturingElectronics engineeringRoot cause analysisPCB designLabViewCAD/SolidWorksProject managementQuality Management SystemsHuman factors engineeringUsability engineeringMedical device safety standardsOrganizational skills

Required

Strong mechanical design engineer

Extensive sustaining product design

Strong electronics/electrical engineering experience working with PCB's, components, electrical systems

Skilled with project management, manufacturing and root cause analysis

5+ years of sustaining engineering experience in a highly regulated environment

Ideally medical device industry experience and knowledgeable of regulatory requirements

Ability to work with electronics and experience with developing PCB schematics and layout design

Ability to read electrical engineering documentation including schematics

Strong project management and organizational skills

Experience with LabView or other test software language/platform

Knowledgeable of Quality Management Systems for Medical Devices ISO 13485, human factors engineering and usability engineering for medical devices IEC 60606-1-6, IEC 62366, ANSI/AAMI HE75 and medical device safety standards IEC 60601