Lead Sustaining Engineer

2 weeks 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:

Key Responsibilities:

  • Act as the primary technical resource for all product design issues related to manufactured goods and acquired components.
  • Lead initiatives to conduct root cause analyses, address challenges, and implement modifications to product and manufacturing processes.
  • Utilize appropriate problem-solving methodologies (such as DMAIC, FMEA, Ishikawa, 5-Whys) to investigate and resolve corrective and preventive actions.
  • Monitor product issues, ensuring effective and timely resolutions while tracking relevant metrics.
  • Assist in the establishment and upkeep of processes used in internal and external manufacturing, as well as depot repair and field service operations. Address and prevent production delays stemming from supplier, process, or quality issues.
  • Champion continuous improvement and Value Engineering projects for existing products.
  • Oversee team efforts to enhance customer satisfaction, improve product quality, boost manufacturing yield, minimize product variability, and reduce costs.
  • Provide engineering assistance for component obsolescence challenges.
  • Support product compliance and safety initiatives (including IEC 60601, REACH, ROHS, CE, etc.).
  • Facilitate change management across product lines, including drafting and coordinating Engineering Change Orders.
  • Contribute to the design and testing of new products by providing effective Design for Manufacturing feedback.
  • Ensure medical device design documentation adheres to FDA design controls, good documentation practices, ISO 9001, and maintain 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, ideally within the medical device sector manufacturing 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 Black Belt or Green Belt certification.
  • 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).
  • Familiarity with Agile methodologies.

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 determined by various factors, including education, experience, location, job responsibilities, and certifications.

Innova Solutions provides a comprehensive benefits package (subject to eligibility), including 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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