Sustaining Engineer, Mechanical/Systems (Madison WI)

Job Title

Sustaining Engineer, Mechanical/Systems (Madison WI)

Requisition

JR000014475 Sustaining Engineer, Mechanical/Systems (Madison WI) (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

Job Description

The Sustaining Engineer, Mechanical/Systems, plays a crucial role in providing expert technical guidance and support to the manufacturing team, particularly in the areas of design, sustaining, manufacturing, and quality engineering. This position is instrumental in helping the business achieve its goals related to quality, customer satisfaction, cost efficiency, and safety. The role involves identifying, developing, and executing key initiatives that align with the company’s objectives, such as quality improvements, customer satisfaction, cost reductions, supplier enhancements, new product introductions, and ensuring product safety. As an integral member of the product life cycle management team, this professional must demonstrate high agility and resilience, adeptly transitioning between projects and assignments while maintaining top-tier engineering performance. Operating within a cGMP environment focused on medical devices, this role demands an unwavering commitment to patient safety and customer satisfaction. 

• Implement process and product changes to address field product issues.

• Develop processes and procedures to ensure compliance with regulatory requirements.

• Execute process and product changes to resolve internal quality concerns.

• Develop manufacturing strategies for the introduction of new products.

• Troubleshoot and resolve system-level design and production challenges.

• Conduct component research, select suitable components, and recommend suppliers.

• Execute these essential functions independently, with potential leadership of small teams, including internal and external resources.

Education / Experience / Skills:

• Education – 4-year degree in Mechanical Engineering or a related discipline.  Significant work experience in medical devices may be substituted in lieu of degree.

• Experience – 3+ years of experience in complex medical device design, sustaining or manufacturing engineering role

• Experience – proficiency in CAD design using SolidWorks

• Skills – High degree of interpersonal, influencing skills, negotiation and team skills.  High degree of supervision/project coordination skills.  Complex problem-solving skills.  In-depth understanding of cGMP requirements, ISO 13485 and other regulatory requirements.

Preferences:

• Experience with Engineering Change Management, system-level troubleshooting of electro-mechanical and electro-pneumatic systems, and mechanical engineering analysis (fit, tolerance, machinability, finite element).

• Proficient in Pro-E, root cause analysis, CAPA, and documentation review.

• Skilled in risk management, managing small engineering teams and projects, and Design for EMC compliance.

• Knowledgeable in mold flow analysis, pneumatic/electromechanical component selection, 3D printing, and interpreting product/manufacturing requirements.

• Experienced in environmental testing, statistical failure analysis, automatic/semi-automatic test systems, and respiratory care device engineering.

This position routinely interacts with areas responsible for product performance, including but not limited to Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues.  This is an Intermediate level role requiring in depth product and therapy understanding across multiple use cases.  In-depth understanding of key stakeholders' needs is essential, as this role will often interact cross functionally as a technical resource.

Working conditions are those typically found in a final assembly and test environment for medical devices.  Workspaces include office environment, sustaining engineering laboratory and device assembly environment.  Some travel both domestic and international will be required up to 20%.

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