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
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you!
Preeti Sehgal
PAY RANGE AND BENEFITS: Pay Range*:$130000 - $160000 *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).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or
. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.
