JOB REQUIREMENTS: Innova Solutions is immediately hiring for a Sr.
Sustaining Engineer Position type: Full Time Perm Location: Middleton,
WI As a Sr. Sustaining Engineer you will: Job Description: The
successful candidate must be highly organized with prior experience in
manufacturing sustaining roles including robust knowledge of mechanical,
electrical, systems, and test engineering, and will use these strengths
to help drive issue resolution in collaboration with cross-function
teams. This candidate must also be able to succeed in an entrepreneurial
environment and not be hindered by ambiguity or competing priorities.
This role is heavily slanted toward product sustaining, ie. dealing with
everything that arises during the years of manufacturing a product such
as component obsolescence, design changes required to improve
performance/aesthetics/marketability/etc., quality concerns (yield
improvement), product cost improvement, field issue investigations, etc.
This type of engineer will be required to often change the product
design to meet the new need.. including mechanical and/or electrical
changes What you\'ll get to do in this role: * Serve as the next-level
of technical support for all product design-related matters related to
released manufactured products and purchased components. * Lead efforts
to perform root cause analyses, resolve issues, implement product and
manufacturing process changes, modifications, and design enhancements.
* Investigate and resolve corrective and preventative actions using
appropriate problem-solving techniques (DMAIC, FMEA, Ishikawa, 5-Whys,
etc.). * Track product issues, drive effective and swift resolution,
and monitor metrics associated with the team\'s work. * Support the
implementation and maintenance of processes utilized in internal and
external manufacturing, and depot repair and field service activities.
Prevent and/or respond to production stoppages due to supplier, process,
or quality related matters. * Drive continuous improvement and Value
Engineering initiatives on released product. * Lead team efforts aimed
toward improving customer satisfaction, product quality improvement,
manufacturing yield improvement, reducing product variability, and
reducing the cost of goods sold. * Provide engineering support for
component obsolescence issues. * Provide engineering support for
product compliance and safety (IEC 60601, REACH, ROHS, CE, etc.). *
Support change management across product lines, including drafting and
coordinating the implementation of Engineering Change Orders. * Support
the design and testing of new products via effective Design for
Manufacturing feedback. * Deliver medical device design documentation
compliant with FDA design controls, good documentation practices, ISO
9001, and ISO 13485. Maintain medical device Design History Files and
Device Master Records. * Support the development, change, and release
of design documentation according to the Quality Management System,
including design artifacts such as BOMs, drawings, pFMEAs, dFMEAs, work
instructions, and manufacturing procedures. What we are looking for:
Basic qualifications Bachelor\'s degree (B.S.) from an accredited,
four-year university or college in electrical, mechanical, systems, or
biomedical engineering, or similar degree. * 5+ years of sustaining
engineering experience, preferably in the medical device industry
manufacturing electro-mechanical products. * Experience with component
obsolescence issues required * Strong project management and
organizational skills. * Ability to work with electronics, PCs and
operating systems (understanding and proficiency), and MS Office
applications including MS Project * Ability to read schematics and
other electrical/electronic e To view the full job description please
use the link below.
https://www.aplitrak.com/?adid=YmJnZW5lcmljLjM1NDEwLjg3NzBAYWNzaWNvcnBjb21wLmFwbGl0cmFrLmNvbQ
***** APPLICATION INSTRUCTIONS: Apply Online:
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