Sustaining Engineer - Risk & Compliance Lead

americas-cookmedical; Indiana (PA); On-site; USD 80,000 - 110,000; Full time

Job summary

Cook Inc. Spencer is seeking a Sustaining Engineer to lead product and process remediation and sustain activities for commercially available products.

You will interface with contract engineers, development engineering, production engineering, product management, regulatory, quality engineering, quality assurance, operations, sourced vendors and physicians as necessary to progress projects/tasks; manage multiple project timelines and risks; analyze risk using CEA and current FMEAs; follow Design

Qualifications

• Bachelor's degree in engineering or engineering technology or equivalent background.
• Previous project management experience preferred.
• Knowledge of statistical practices related to sample sizes, confidence intervals, capability, risk and problem solving.
• Proficient with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

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)

Skills

Project management

Risk analysis

Statistics

Windows software

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Word

Excel

Project

PowerPoint

Visio

Job description

Cook Inc. Spencer is seeking a Sustaining Engineer to lead product and process remediation and sustain activities for commercially available products.

You will interface with contract engineers, development engineering, production engineering, product management, regulatory, quality engineering, quality assurance, operations, sourced vendors and physicians as necessary to progress projects/tasks; manage multiple project timelines and risks; analyze risk using CEA and current FMEAs; follow Design