Process Validation Engineer – MedTech (Hybrid)

Getinge; Fraser (MI); Hybrid; USD 75,000 - 94,000; Full time

Benefits offered by this job

Health insurance

401k with company match

Paid time off

Wellness program

Life Insurance

Disability benefits

Tuition reimbursement

Job summary

Getinge is seeking an engineer to assist with developing and optimizing manufacturing processes for products transitioning to production for commercial release. The role focuses on collaborative process improvements and ensuring quality systems are upheld.

The candidate will work with equipment and process changes, perform protocol preparation, and support training and documentation efforts across manufacturing teams.

Qualifications

• Bachelor's degree in engineering is required.
• Minimum 3 years of medical device experience.
• Strong written and verbal communication skills.
• Experience in cross-functional teams is preferred.

Responsibilities

• Collaborate with engineers to develop and optimize processes for new products.
• Prepare IQ/OQ/TMV/PQ protocols and reports.
• Execute IQ/OQ/TMV/PQ protocols and validate results.
• Assist with process risk documentation (pFMEA).
• Coordinate pilot production and pre-release manufacturing.
• Support release of new processes and equipment into production.
• Assist training on new equipment and processes.
• Create and maintain documentation including equipment history files, procedures, test methods, BOMs, routings, etc.
• Manage change orders (ECO/DCO) for release or updates of controlled items.
• Maintain compliance with Quality System and regulatory requirements.
• Contribute to special projects and team goals.

Skills

Communication

Cross-functional teamwork

Process development

Equipment introduction

Statistical analysis

Education

Bachelor's Degree in Engineering

Job description

Getinge is seeking an engineer to assist with developing and optimizing manufacturing processes for products transitioning to production for commercial release. The role focuses on collaborative process improvements and ensuring quality systems are upheld.

The candidate will work with equipment and process changes, perform protocol preparation, and support training and documentation efforts across manufacturing teams.