Sustaining Engineer

TITLE: Senior Sustaining Engineer

LOCATION: Middleton, WI

EMPLOYMENT TYPE: Direct-Hire

PAY: $130,000

BENEFITS: Medical, Dental, and Vision insurance, 401k, sick leave, and employee assistance program, PTO, paid holidays, and more!

ROLE & RESPONSIBILITIES

We are seeking a Sustaining Engineer for one of our exciting class II medical device clients in Middleton, WI! You will serve as the Technical Lead, overseeing medical devices across the full product lifecycle. This is an immediate direct-hire, onsite position and the hiring manager is seeking:

• Strong mechanical design engineer
• Extensive sustaining product design
• Medical device manufacturing experience preferred (Class II or III)
• Strong electronics/electrical engineering experience working with PCB’s, components, electrical systems
• Skilled with project management, manufacturing and root cause analysis

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

ESSENTIAL QUALIFICATIONS

• Education: B.S. degree in Mechanical, Electrical engineering or equivalent preferred
• 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
• Familiarity with CAD, SolidWorks preferred
• 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

WHY AVERRO?

Averro is a Veteran-Owned organization dedicated to delivering innovative talent solutions, business consulting, and technology services that propel businesses and careers forward. We live by our ethos: Be Curious | Build Trust | Empower Each Other. These values show in our commitment to client satisfaction, timely support, and unmatched consultant care. Our Aim – Your Ascent.

Averro is an equal opportunity employer, and we are committed to diversity, equity, and inclusion in the workplace. All qualified applicants will receive consideration for employment, regardless of criminal histories, consistent with legal obligations. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

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