Getinge · 3 days ago
Engineer II, Product Sustaining
Wayne, NJ
Full-time
Onsite
Mid Level
$94K/yr - $97K/yr
3+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, and collaborating with component suppliers.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data
Write and execute Test Method Validations. Compile, analyze and report testing data
Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents
Investigate and plan CAPA activities
Communicate and Coordinate activities with other Getinge sites and outside component suppliers
Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, and other documentation)
Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan
Develop processes, methods, tooling, and production controls; supervises their assembly and proofing
Prepares presentations reflecting the status and results of projects
Lead small projects that support product enhancement and cost savings opportunities
This is not an inclusive list of job responsibilities
Qualification
Required
Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 3-6 years of related experience
General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements
Experience with process and equipment validations/qualifications
Experienced with laboratory physical testing methods Validation/Verification
Process Validation/Verification
Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
Must have strong technical and analytical ability; detail oriented
Must have good verbal and written communication skills
Strong interpersonal skills
Good organizational skills. Must be able to adhere to timelines
Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks
Basic understanding of statistical analysis
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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