Engineer 1, Sustaining

Cook Group; Indiana; On-site; USD 65,000 - 95,000; Full time

Job summary

Cook Inc. Spencer is seeking a Sustaining Engineer to lead product and process remediation activities and sustain existing products in the market.

You will work with contract, development, production engineering, regulatory, quality, and operations teams to drive remediation tasks and maintain existing device specifications. The role emphasizes risk analysis (CEA, FMEAs), adherence to design controls per 21 CFR 820 and ISO standards, and collaboration across departments to execute testing and

Qualifications

• Bachelor's degree in engineering or related field.
• Project management experience preferred.
• Knowledge of statistical practices for risk assessment and sampling.
• Proficiency with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

Responsibilities

• Interface with cross‑functional teams to progress projects/tasks.
• Manage multiple project timelines, resources and responsibilities to achieve goals.
• Analyze risk using CEA and current FMEAs.
• Follow Design Control procedures and comply with 21 CFR 820, ISO 13485 and ISO 14971 as applicable.
• Identify user needs and develop into design input requirements.
• Formulate Verification & Validation Test Plan and collaborate with Cook departments to execute testing.
• Update device and production specifications accordingly.
• May mentor/coach technicians or other engineering employees (co-ops/interns).

Skills

Project management

Statistics

Microsoft Office

Education

Bachelor's degree in Engineering

Job description

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 withother 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)