Job Description:

Job Title

Sustaining Engineer (Madison, WI)

Requisition

JR000011493 Sustaining Engineer (Madison, WI) (Open)

Location

CC-Madison - USA503

Additional Locations

Madison, WI

Job Description

Summary

The Sustaining Engineer - Electrical provides expert guidance and support to the manufacturing, complaint and service teams in the areas of sustaining, manufacturing, design and quality engineering as well as root cause analysis to help achieve the business goals for quality, customer satisfaction, cost and safety. This position is responsible for identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for quality improvements, customer support and satisfaction, existing product support, supply chain viability, manufacturability, serviceability, supplier initiatives, new product introductions, product safety and cost reductions. This position requires excellent written and oral communication skills. As an active member of the product life cycle management team, this professional will have a high level of agility, resiliency with the ability to quickly move between multiple simultaneous projects and assignments, while maintaining the highest degree of engineering performance. Working in a cGMP environment related to medical devices, this position must possess a constant focus on patient safety, compliance and customer satisfaction. Although this is not a design engineering position, it is expected that input will be provided to support new designs.

Essential Functions

• Investigation and System-level troubleshooting of electro-mechanical and electro-pneumatic systems composed of hardware and software


• Electrical Engineering Analysis (Analog/Digital)


• Root cause analysis


• Process/product changes to resolve field product problems


• Medical Device Report generation and review


• Engagement in cross-functional teams


• Process and procedures to comply with regulatory requirements


• Process/product changes to resolve internal quality problems


• Resolving system-level design/production problems


• Conducting component research/selection and recommendation of suppliers

Minimum Requirements

Education / Experience / Skills:

• Education - BS in electrical engineering.


• Experience - 2-5 years of experience in sustaining engineering, manufacturing engineering or customer/service support roles


• Skills - High degree of interpersonal, influencing skills, negotiation and team skills.


• Solid written and oral communication skills.


• Complex problem solving skills.


• Understanding of cGMP requirements, ISO 13485 and other regulatory requirements.


• Risk management - participation in risk analysis and interpretation of risk management files for CAPA/FMEA

Preferred Experience:

• Medical device experience (especially respiratory care)


• Experience with CAPA


• Statistical methods for analysis of failures, reliability and process capability


• Software Structure/Logic


• Interpreting product and manufacturing requirements


• Experience with network connected cyber-secure medical products


• Experience with functional and/or ICT circuit board testing


• Exposure to CAD tools for electrical and mechanical design


• Exposure to EMC compliance


• Exposure to Product Test Requirements


• Exposure to automatic/semi-automatic test equipment systems


• Participation in and/or leadership of small teams

Organizational Relationship/Scope:

This position routinely interacts with colleagues, including those responsible for but not limited to Product Performance, Complaint Management, Service Support, Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues and new product introduction. This role will often interact cross- functionally as a technical resource, leveraging prior technical experience and that gained through on the job training

Working Conditions:

Working conditions are those typically found in a final assembly and test environment for medical devices. Work spaces 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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