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Engineer 1, Sustaining

Cook MyoSite · Spencer, IN

Engineer 1, Sustaining Requisition ID 2026-18802 Posting Date 3 weeks ago (7/15/2026 8:37 AM) Job Location(s) Spencer IN United States Job Locations US-IN-Spencer Travel Less than 10% Position Type Full Time Company Cook Inc - Spencer Category Engineering Overview The Sustaining Engineer at Cook Inc. Spencer 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 mentor/coach technicians or other engineering employees (co-ops/interns) Qualifications • Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background • 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) Options Apply for this job online Apply Share Share the job posting with a friend Refer Sorry the Share function is not working properly at this moment.

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Engineer 1, Sustaining at Cook MyoSite | BioCareerAI