Lead Sustaining Engineer

2 weeks ago

Middleton, United States Innova Solutions Full time

Innova Solutions is 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 a solid background in manufacturing support roles, demonstrating extensive knowledge in mechanical, electrical, systems, and testing engineering. This expertise will be utilized to facilitate problem resolution in partnership with cross-functional teams. The candidate should thrive in a dynamic environment, adept at navigating ambiguity and competing priorities. This position is primarily focused on product support, addressing challenges that arise throughout the product lifecycle, including component obsolescence, necessary design modifications for performance or aesthetic enhancements, quality improvement initiatives, and cost reduction strategies. The engineer will frequently need to adapt product designs to meet evolving requirements, encompassing both mechanical and electrical adjustments.

Key Responsibilities:

  • Act as the primary technical resource for all design-related inquiries concerning released products and purchased components.
  • Lead root cause analysis efforts, resolve issues, and implement modifications and enhancements to products and manufacturing processes.
  • Conduct investigations and resolve corrective and preventive actions utilizing effective problem-solving methodologies (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).
  • Monitor product issues, ensuring prompt resolution and tracking metrics associated with team performance.
  • Support the implementation and upkeep of processes used in both internal and external manufacturing, as well as depot repair and field service operations, addressing production interruptions due to supplier, process, or quality issues.
  • Drive continuous improvement initiatives and Value Engineering efforts for released products.
  • Lead initiatives aimed at enhancing customer satisfaction, product quality, manufacturing yield, and reducing product variability and costs.
  • Provide engineering assistance for component obsolescence challenges.
  • Ensure compliance with product safety and regulatory standards (IEC 60601, REACH, ROHS, CE, etc.).
  • Facilitate change management across product lines, including drafting and coordinating Engineering Change Orders.
  • Assist in the design and testing of new products through effective Design for Manufacturing feedback.
  • Prepare medical device design documentation in accordance with FDA design controls and good documentation practices, while maintaining Design History Files and Device Master Records.
  • Support the development, modification, and release of design documentation as per the Quality Management System, including essential 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 university 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 focused on electro-mechanical products.
  • Experience addressing component obsolescence issues is essential.
  • Strong project management and organizational capabilities are required.
  • 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 within 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).
  • Experience in human factors and usability engineering for medical devices, as well as medical device safety standards.
  • Familiarity with Agile methodologies.

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

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, flexible spending accounts, life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, legal and identity theft protection, sick leave, and other paid leave options as mandated by law, along with an Employee Assistance Program (EAP).

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