Lead Sustaining Engineer

1 week ago

Middleton, United States Innova Solutions Full time

Innova Solutions is currently seeking a Senior Sustaining Engineer.

Position Type: Full Time Permanent

Location: Middleton, WI

As a Senior Sustaining Engineer, your responsibilities will include:

Role Overview:

The ideal candidate will possess exceptional organizational skills and have prior experience in manufacturing support roles, demonstrating a solid understanding of mechanical, electrical, systems, and testing engineering. This expertise will be utilized to facilitate issue resolution in partnership with cross-functional teams. The candidate should thrive in a dynamic environment, effectively managing ambiguity and competing priorities. This position is primarily focused on product support, addressing challenges that arise during the lifecycle of a product, such as component obsolescence, necessary design modifications for enhanced performance, quality improvements, and field issue investigations. The engineer will frequently adapt product designs to meet evolving requirements, including mechanical and/or electrical adjustments.

Key Responsibilities:

  • Act as the primary technical resource for all product 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 preventative actions using established problem-solving methodologies (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).
  • Monitor product issues, ensuring effective and timely resolutions while tracking relevant metrics.
  • Support the establishment and upkeep of processes utilized in internal and external manufacturing, as well as depot repair and field service operations, to prevent or respond to production interruptions.
  • Drive continuous improvement and Value Engineering projects for released products.
  • Lead team initiatives aimed at enhancing customer satisfaction, product quality, manufacturing yield, and reducing product variability and costs.
  • Provide engineering support for component obsolescence challenges.
  • Assist with product compliance and safety requirements (IEC 60601, REACH, ROHS, CE, etc.).
  • Facilitate change management across product lines, including drafting and coordinating 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 and good documentation practices, maintaining 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:

Applicants should possess a Bachelor's degree (B.S.) from an accredited four-year university or college in electrical, mechanical, systems, or biomedical engineering, or a related field.

  • A minimum of 5 years of experience in sustaining engineering, preferably within the medical device sector, focusing on electro-mechanical products.
  • Experience addressing 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 may be necessary.

Compensation and Benefits:

The pay range for this position is $135K, with the final offer based on various factors including education, experience, location, and specific job responsibilities.

Innova Solutions provides a comprehensive benefits package, which may include medical and pharmacy coverage, dental and vision insurance, 401(k), health savings accounts (HSA), flexible spending accounts (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, legal and ID theft protection, sick leave, and other paid leave options as mandated by law, along with an Employee Assistance Program (EAP).

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