Sustaining Engineer – Risk, Validation & PM

Cook Group; Indiana (PA); On-site; USD 80,000 - 115,000; Full time

Job summary

Cook Group in Spencer, Indiana is seeking a Sustaining Engineer to lead remediation efforts and sustain products currently in the market. You will interface with contract engineers, development, regulatory, quality, and operations teams to advance projects end-to-end.

The role emphasizes risk analysis, design control compliance with 21 CFR 820 and ISO standards, and updating specifications. Mentoring of technicians/interns may be involved.

Qualifications

• Bachelors degree in engineering or related field.
• Project management experience preferred.
• Knowledge of statistical practices related to sampling, confidence intervals, capability, risk and problem solving.
• Experience with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

Responsibilities

• Interface with contract engineers, development, regulatory, QA, operations and vendors to progress projects.
• Manage multiple project timelines, resources and responsibilities to meet 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 translate into design input requirements.
• Formulate verification & validation test plans 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

Risk analysis

Problem solving

Statistical methods

Education

Bachelor's Degree in Engineering or Engineering Technology

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft PowerPoint

Visio

Job description

Cook Group in Spencer, Indiana is seeking a Sustaining Engineer to lead remediation efforts and sustain products currently in the market. You will interface with contract engineers, development, regulatory, quality, and operations teams to advance projects end-to-end.

The role emphasizes risk analysis, design control compliance with 21 CFR 820 and ISO standards, and updating specifications. Mentoring of technicians/interns may be involved.