Senior Product Support Engineer

2 weeks ago

Middleton, Wisconsin, United States Innova Solutions Full time

Innova Solutions is currently seeking a Senior Product Support Engineer.

Position Type: Full Time Permanent

Location: Remote

As a Senior Product Support Engineer, your responsibilities will include:

Key Responsibilities:

The ideal candidate will be exceptionally organized and possess substantial experience in manufacturing support roles, with a solid understanding of mechanical, electrical, systems, and testing engineering. This expertise will be utilized to facilitate problem resolution in collaboration with cross-functional teams. The candidate should thrive in a dynamic environment, adept at navigating ambiguity and competing priorities. This position focuses primarily on product support, addressing challenges that arise during the lifecycle of a product, including component obsolescence, necessary design modifications for enhanced performance and marketability, quality assurance (yield enhancement), cost reduction, and field issue investigations. This role may require alterations to product designs to accommodate new requirements, including mechanical and/or electrical adjustments.

Responsibilities Include:

  • Act as the primary technical resource for all design-related inquiries concerning released manufactured products and purchased components.
  • Lead initiatives to conduct root cause analyses, resolve issues, and implement modifications and enhancements to products and manufacturing processes.
  • Investigate and address corrective and preventive actions utilizing appropriate problem-solving methodologies (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).
  • Monitor product issues, ensure effective and timely resolutions, and track metrics associated with the team's performance.
  • Support the establishment and maintenance of processes used in internal and external manufacturing, as well as depot repair and field service operations. Address production interruptions stemming from supplier, process, or quality-related issues.
  • Champion continuous improvement and Value Engineering initiatives for released products.
  • Lead efforts aimed at enhancing customer satisfaction, improving product quality, increasing manufacturing yield, reducing product variability, and lowering costs.
  • Provide engineering assistance for component obsolescence challenges.
  • Assist with product compliance and safety standards (IEC 60601, REACH, ROHS, CE, etc.).
  • Facilitate change management across product lines, including drafting and coordinating the implementation of Engineering Change Orders.
  • Support the design and testing of new products through effective Design for Manufacturing feedback.
  • Ensure medical device design documentation adheres to FDA design controls, good documentation practices, ISO 9001, and maintain medical device Design History Files and Device Master Records.
  • Assist in the development, modification, and release of design documentation in accordance with the Quality Management System, including design artifacts such as BOMs, drawings, pFMEAs, dFMEAs, work instructions, and manufacturing procedures.

Qualifications:

Basic qualifications include:

  • Bachelor's degree (B.S.) from an accredited university in electrical, mechanical, systems, or biomedical engineering, or a related field.
  • 5+ years of experience in sustaining engineering, preferably within the medical device sector, focusing on electro-mechanical products.
  • Experience managing component obsolescence issues is essential.
  • Strong project management and organizational capabilities.
  • Proficiency in working with electronics, PCs, operating systems, and MS Office applications, including MS Project.
  • Ability to interpret schematics and other electrical/electronic engineering documentation.

Preferred Skills:

  • Lean Six Sigma certification (Black Belt or Green Belt).
  • Familiarity with SMT manufacturing processes.
  • Experience with LabView or similar testing software platforms.
  • Knowledge of regulatory standards in the medical device industry.
  • Experience with FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO 14971), and Quality Management Systems for Medical Devices (ISO 13485).
  • Background in human factors engineering and usability engineering for medical devices (IEC 62366, ANSI/AAMI HE75) and medical device safety standards (IEC 60601).
  • Agile methodology experience.

Travel Requirements: Up to 15% domestic and/or international travel as needed.

Benefits: Innova Solutions offers a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick leave, and other paid leave as required by law, along with an Employee Assistance Program (EAP).

About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals globally and reports an annual revenue nearing $3 billion. Through our global delivery centers across North America, Asia, and Europe, we provide strategic technology and business transformation solutions to our clients, empowering them to excel in their respective fields.

Recent Recognitions:

  • Ranked as one of the largest IT consulting staffing firms in the USA - recognized as #4 by Staffing Industry Analysts (SIA 2022).
  • Recipient of the ClearlyRated Client Diamond Award (2020).
  • One of the largest certified MBE companies in the NMSDC Network (2022).
  • Advanced Tier Services partner with AWS and Gold partner with Microsoft.

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