Senior Sustaining Engineer

3 weeks ago

Middleton, United States Innova Solutions Full time

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 engineering documentation.

Desirable Skills:

Lean Six Sigma Black Belt or Green Belt; Knowledge of SMT manufacturing processes; Experience with LabView or other test software language/platforms; Knowledge of regulatory requirements in medical device industry; Experience in FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO 13485]; Experience in 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]. Agile

Travel Required: 15% domestic and/or international travel on an as needed basis

Thank you

Preeti Sehgal

PAY RANGE AND BENEFITS:

Pay Range*:$130K

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

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