Getinge · 6 days ago
Sr. Engineer, Production (Technical Writer)
Merrimack, NH
Full-time
Hybrid
Senior Level
$95K/yr - $120K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a Senior Engineer, Manufacturing Engineering Technical Writer who will be responsible for writing Nonconformance Reports and developing Quality Assurance methodologies to support the NCR system, while ensuring compliance with medical device quality standards.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Write complex NCR’s, which include the investigation, product or equipment disposition, actions plans, and closure
Support crash carts for within the Controlled Environment (CE) as needed
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet internal and external requirements
Provide support on CAPA’s
Engage in in Material Review Board (MRB) activities: including defect disposition, rework and sort instructions, and documentation of nonconformances
Perform root cause / corrective action analysis of failures in accordance with our corrective action process
Drive change and continuous improvements primarily within the NCR system
Provide cross functional support for complex root cause investigations, risk assessments and corrective actions through the NCR or CAPA process
Collaborate with other Manufacturing Engineers (ME’s) on problem solving and root cause analysis activities
Partner with ME’s with specific product line production quality issues
Assess and mitigate risk associated with manufacturing activities related to NCR’s
Identify, analyze and resolve product and process problems within the NCR system
Collaborate with quality teams, operations personnel and other stake holders to gather technical information, validate content accuracy, and drive NCR’s to completion
Drive the reduction of product and process non-conformances
Collaborate with manufacturing and other cross-functional teams to drive continuous improvement initiatives within the NCR system
Completes assigned Manufacturing Engineering tasks related to QMS systems in a timely manner
Deep understanding of the Quality and Regulatory requirements within a medical device manufacturing company
Qualification
Required
Bachelor's degree in engineering / science, or advanced degree, or equivalent work experience
A minimum of 5-7 years of Quality Management Systems (QMS) experience
Excellent problem solving, communication and writing skills
Experience in the Medical Device Manufacturing industry or similar
Deep understanding of the Quality and Regulatory requirements within a medical device manufacturing company
Preferred
Advanced writing skills that hold up to audit scrutiny
Advanced analytical and problem solving skills
High level of attention to detail and accuracy
Self-motivated, proactive, and comfortable working with limited supervision as skills develop
Exceptional computer skills, including MS Office applications (Word/Excel), PLM – Agile, and statistical software (Mini-Tab)
Ability to work collaboratively with Production, Quality, ME, Procurement and other cross-functional teams
Advanced knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation
Knowledge of ISO 13485 and 14971 and 21CFR Part 820
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
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2025-12-19
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