Senior Engineer, Process Validation

Getinge • Fraser, MI

8d • $94,000 - $118,000

About The Position

Lead equipment and process qualification initiatives for existing and new product lines.

Requirements

• Problem solving / troubleshooting skills.
• Excellent communication skills.
• Able to work in a cross functional team environment.
• Computer skills including MS Office Suite (Word, Excel, etc.).
• Experience with introducing equipment and process qualification required.
• Experience with process control & statistical analysis techniques required.
• Experience in a medical device environment or other regulated industry is required.
• Bachelor’s Degree required (Engineering degree preferred)
• 5+ years medical device validation experience required (10+ preferred)

Nice To Haves

• Experience with PLM software preferred.

Responsibilities

• Responsible for Process Validation.
• Responsible for processing ECO’s.
• Supports Production and Manufacturing operations.
• Responsible for manufacturing methods and their transfer into production.
• Engineering support, including but not limited to vendor contact and auditing specification.
• Responsible for Process Risk Management.
• Provide assistance for equipment design for producing medical devices and components as required.
• Responsible for manufacturing methods and their transfer into production.
• Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production.
• Modify and improve existing equipment. Improve manufacturing efficiency, production yeilds, product quality and consistency through equipment and design modifications and fabrications.
• Maintain compliance to Quality System and regulations for new processes and equipment.
• Assist in special projects as needed.
• Contribute to team effort by accomplishing related duties as requested.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees