Getinge · 4 days ago
Engineer II, Process
Merrimack, NH
Full-time
Onsite
Mid Level
$80K/yr - $105K/yr
3+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Engineer II, Process role involves working cross-functionally between product development and manufacturing engineering to develop and optimize new manufacturing processes and equipment for commercial release.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Provide input to Product Development on new product designs to address Design for Manufacturing (DFM) and Design for Assembly (DFA) requirements
Act as a liaison between Product Development, Manufacturing, and Manufacturing Engineering to assure that project deliverables are communicated and agreed upon
Assess process failure risks and institute methods of detection and mitigation
Develop & optimize processes required for new products & equipment
Work with internal design/equipment engineers and/or outside equipment vendors to specify, purchase and develop new manufacturing equipment and tooling
Work with validation and quality engineers to develop validation plan for new equipment / processes
Maintain compliance to Quality System and regulations for new processes and equipment
Complete protocols and reports for Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ)
Collaborate with other disciplines as needed to execute Performance Qualification (PQ) activities
Coordinate pilot production / pre-release manufacturing
Work closely with Manufacturing and Manufacturing Engineering to release new processes and equipment into production
Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production
Create and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM’s, routings, etc
Responsible for change orders (ECO/DCO’s) required to release and/or update controlled items
Assist in special projects as needed
Contribute to team effort by accomplishing related duties as requested
Qualification
Required
Bachelor's Degree in Engineering, or equivalent work experience
Minimum of 3 years of process engineering, manufacturing engineering, or other related experience
Experience with developing and optimizing new manufacturing processes
Experience with introducing new equipment / processes into production
Strong problem solving / troubleshooting skills
Experience with process control & statistical analysis techniques
Excellent communication skills with the ability to present technical information and prepare written reports
Able to work in a cross functional team environment
Strong computer skills including MS Office Suite (Word, Excel, etc.)
Build Quality into all aspects of their work by maintaining compliance to all quality requirements
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function)
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function)
Attend all required Quality & Compliance training at the specified interval
Adopt the 'Beyond Compliance Quality Culture' in the work environment; always meet and exceed requirements
Preferred
Project management experience is preferred
Experience in a medical device environment or other regulated industry is 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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