Engineer 1, Sustaining

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

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)