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Sustaining Engineer
Company : Cook Medical
Location : Spencer, IN, 47460
Job Type : Full Time
Date Posted : 2 January 2026
Overview
The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
Responsibilities
• Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks• Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals• Analyze risk using CEA and current FMEAs • Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable• Identify user needs and develop into design input requirements • Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing
• Update device and production specifications accordingly • May supervise / coach technicians or other engineering employees
Qualifications
• Bachelors Degree in Biomedical or Mechanical Engineering
• Medical Device/Life Science experience perferred
• Previous project management experience preferred
• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
• Knowledgeable with Windows based software (i.e. Word, Excel, Project, Power Point, Visio)
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
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Frequently asked questions
Mastery of biomedical or mechanical engineering principles, proficiency with Windows-based tools like Excel and Visio, and understanding FDA regulations such as 21CFR820 are vital. Additionally, skills in risk analysis and quality assurance ensure effective product support and continuous improvement in medical device sustainability.
Sustaining Engineers focus heavily on post-market product remediation and cross-functional collaboration, managing multiple timelines to maintain commercial product quality. Unlike development roles, the emphasis is on addressing issues in existing products and driving process improvements to uphold regulatory compliance.
Career progression often leads toward senior engineering roles, project management, or quality system leadership. Gaining expertise in regulatory affairs and continuous improvement methodologies can open doors to supervisory positions or specialized consulting within the medical device industry.
While a bachelor's degree in biomedical or mechanical engineering is essential, certifications like Six Sigma or ISO 13485 familiarity can strengthen candidacy. In Spencer, employers value candidates who understand FDA regulations and have hands-on experience with quality management systems common in medical device manufacturing.
Spencer’s niche in medical device manufacturing creates moderate demand for sustaining engineers, though competition is relatively lower than metropolitan areas. Candidates with project management experience and regulatory knowledge tend to stand out, as Cook Medical and similar companies seek professionals who can efficiently manage product lifecycles.
Most employees in Spencer experience manageable commute times due to the town’s smaller size. Cook Medical fosters a collaborative, quality-driven environment emphasizing cross-departmental teamwork. The company culture supports continuous learning and compliance with rigorous medical standards, attracting engineers committed to innovation and precision.
This role acts as a liaison among contract engineers, quality assurance, regulatory teams, and clinicians. By coordinating verification and validation activities, Sustaining Engineers ensure remediation aligns with compliance standards, enabling seamless transitions from development to sustained product support.
Sustaining Engineers in Spencer typically earn between $75,000 and $95,000 annually, reflecting the specialized skills required in biomedical engineering and regulatory adherence. Salaries may vary based on experience, project management expertise, and familiarity with quality systems like ISO 13485.
Cook Medical’s Sustaining Engineer role stands out through its deep involvement in cross-functional collaboration and rigorous adherence to FDA and ISO standards. Unlike some companies, Cook emphasizes both product and process remediation, offering a balanced mix of technical challenges and project leadership opportunities.
Yes, familiarity with quality engineering practices, including FMEAs and design controls, is highly valued. Cook Medical expects Sustaining Engineers to proactively assess risk and ensure compliance with 21CFR820, ISO 13485, and ISO 14971, which are critical for maintaining product safety and efficacy in the medical device arena.