Getinge · 10 hours ago
Senior Engineer, Process Validation
Fraser, MI, US
Full-time
Onsite
Senior Level
$94K/yr - $118K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a Senior Engineer for Process Validation to lead equipment and process qualification initiatives for existing and new product lines, ensuring compliance with quality systems and regulations.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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 yields, 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
Qualification
Required
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
Preferred
Experience with PLM software preferred
10+ years medical device validation experience preferred
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
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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2025-12-19
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