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Project Engineer
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…customers, always striving to exceed expectations on innovation,…
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Sr Field Applications Engineer (FAE)
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…level debug, with the ability to support customers through design, bring up, validation, and issue resolution. This role is well suited for an experienced engineer who can work…
Added 1 min ago
Sr Field Applications Engineer (FAE)
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…level debug, with the ability to support customers through design, bring up, validation, and issue resolution. This role is well suited for an experienced engineer who can work…
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Senior AI Engineer, Release Engineering
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Quince
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…challenge the status quo. Our mission is simple: make really high quality essentials for really low prices, fairly and sustainably. We deliver on that mission through a unique…
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Structural Design Engineer
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…connection and fastener calculations, anchored and embedded systems, barrier wall support structures, light-gauge and cold-formed steel design, and structural vibration and isolation…
Added 6 mins ago
Industrial Engineer 2
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Plays a key role in analyzing, designing, and optimizing systems and processes within manufacturing or operations environment. This position supports and leads moderately complex projects…
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Forward Deployed Engineer - Applied AI
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Build and ship AI features end to end. Design, code, test and deploy LLM-powered features in MedicatOne: prompt design, tool calling, retrieval where it earns its place, and evaluation…
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Maintenance Engineer Supervisor | Buffalo Marriott LECOM HARBORCENTER
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- From $25 USD / hour
Maintains facility and grounds quality based on hotel, Shaner, and Franchise specifications.
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Senior Python Software Engineer III
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…Organization, you are part of an agile team that works to enhance, design, and deliver the software components of the firm’s state-of-the-art risk analytics platforms in a secure, stable,…
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Bridge Inspection Team Leader
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…analysis, as well as other structural engineering tasks for bridge systems. This position offers a dynamic schedule with a mix of on-site field work and office work with other team members.…
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Quality Engineer
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The Quality Engineer will provide hands-on Quality Assurance and Quality Systems support for LifeSprout’s medical-device development, manufacturing, and related operations at the Baltimore…
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Closeout Systems Engineer
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- $75,000 USD / year
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Added 15 mins ago
Senior Software Development Engineer in Test (SDET) - Remote
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Remote, United States
Scalepex is actively seeking an experienced Senior Software Development Engineer in Test (SDET) for an exciting remote opportunity in the digital healthcare technology space.
Added 15 mins ago
Engineer I, Controlled Environments
Getinge
Merrimack, NH
A Quality Engineer I, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and…
Added 15 mins ago
Manufacturing Engineer II
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Lansdale, PA
As a Manufacturing Engineer II here at Honeywell Aerospace, you will play a vital role in supporting the manufacturing processes for RF products, microelectronics, assembly, and testing.…
Added 16 mins ago
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Software Engineer 2
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- $245,000 to $255,000 USD / year
Markon is seeking a Software Engineer Level 2 to support the Fort Meade Customer. This role focuses on developing, testing, and maintaining software solutions using Python, Linux, and…
Added 16 mins ago
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Project Engineer
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New York, NY
- $115,000 USD / year
…metro area - projects that improve mobility, resilience, and quality of life for millions. By uniting deep technical expertise with innovation, collaboration, and an uncompromising…
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Manufacturing Engineer
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Added 18 mins ago
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WIRE HARNESS PROCESS ENGINEER
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- $75,000 to $80,000 USD / year
The Wire Harness Process Engineer is a hands-on technical role focused on translating customer engineering drawings into high-quality manufactured wire harnesses and cable assemblies. This…
Added 18 mins ago
Product Quality Engineer
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The Product Quality Engineer is responsible for ensuring that manufactured products meet all engineering specifications, contractual requirements, and regulatory standards throughout the…
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Lead Underground Transmission Line Engineer 2 - Grid
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Protection and Control Engineer
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We are seeking a highly skilled Protection and Control Engineer with expertise in power systems to join our Shermco team. The ideal candidate will lead complex electrical projects, mentor…
Added 22 mins ago
Practice Lead-Structural Engineering
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…ranging from client development to delivering complex, high‑quality projects focused on steel and concrete infrastructure. Our work centers on diagnostics, remedial design, and consulting,…
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AWS DevOps Engineer
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⦁ Facilitate software application design discussions, and document design decisions to guide the technical team towards building software solutions

Getinge

Engineer I, Controlled Environments

Merrimack, NH, United States

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Job details

Apply by: Jan 2, 2027
Posting language: English
Posted: Nov 5, 2026

Original job description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

A Quality Engineer I, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and Microbiological Testing. This includes development, revision, organization, administration, and compliance of the company’s routine Controlled Environment efficacy programs including Systems Qualification, Environmental Monitoring, and Biological Product Testing. A Quality Engineer, Controlled Environments, shall also perform tasks, as assigned, to support change control, CAPA activities, and other compliance activities related to the Controlled Environment and Contamination Control Programs.

Job Responsibilities and Essential Duties

Development, qualification, maintenance, and nonconformance analysis of a routine testing program for maintenance of a manufacturing environment suitable for the manufacture of medical devices. The program includes, but is not limited to, the following tests:
Air pressure differential measurement
Temperature and %RH measurement (where applicable)
Air Particulate Testing
Microbiological tests of system and testing waters
Biological Air Testing
Bioburden analysis (surface)
Compressed Air and Nitrogen Testing.

Microbiological Testing as part of the sterilization assurance and contamination control program also include the following:

Bacterial Endotoxin analysis of finished goods and in in-process components.
Bioburden analysis (finished goods)
Oversee and/or perform sampling for aforementioned test types as required.
Oversee, perform and/or review controlled environment and microbiological test result data entry.
Maintenance of contamination control, environmental monitoring, and bacterial endotoxin risk assessments.
Ensure continued conformance to existing standards (e.g. ISO 14644 series, ISO 11737-1, and ANSI/AAMI ST72), perform gap analysis for new/revised standards/guidance documents, and maintain compliance by implementing changes to conform (where applicable) to conform to new/revised industry standards.
Representing CE&S for Operations projects working towards optimizing the manufacturing workflow including equipment and work stream relocations.
Representing CE&S in cross functional project teams working towards introducing new products lines or expanding existing lines.
Development of Controlled Environment IQ/OQ/PQ protocols and reports to support facility and operation changes.
Maintenance of Controlled Environment Requalification Program, including generation of protocols/reports.
Generation and ownership of Controlled Environment, Contamination Control and Microbiological Testing CAPA Requests and CAPAs
Representing CE&S in cross function CAPAs where necessary.
Performance and/or supervision of additional departmental analysis, or tasks, including, but not limited to:
Writing, implementing, revising, and, or approving Standard Procedures (SPs), protocols, and reports relating to Controlled Environments.
Authoring, ensuring execution of and approving microbiological test method validations.
Generating Controlled Environment & Microbiological related content and controls within equipment relocation plans, part qualification, supplier change assessments, and design change quality plans.
Nonconformance technical support for controlled environment and product testing excursion events including root cause analysis and investigation.
Development, maintenance, and execution of Environmental and Product Microbiological Testing Trend Analysis Programs
Additional projects as assigned by Departmental Management.
Assists in special projects as needed.
Contributes to team effort by accomplishing related duties as requested.

Minimum Requirements

A Bachelors’ Degree in Engineering, Biology, Microbiology, Chemistry, or a related science and two years’ experience in a medical device or pharmaceutical environment.
Equivalent work experience shall be acceptable in place of education at the discretion of the Manager, CE&S.

Required Knowledge, Skills and Abilities

Highly organized with strong negotiation and communication skills.
Detail oriented with ability to self review
Familiarity with ISO Standards for Controlled Environments and Microbiological Testing
Ability to create and revise technical documentation as well as author position pieces with minimal guidance

Supervision/Management Of Others:

Internal and External Contacts/Relationships

Various

Quality Requirements

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.

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions.
Duties are performed in an office environment.
Duties are performed in a manufacturing/clean room environment.
Personal protective equipment may be required as dictated by work environment.
Some duties may be performed remotely.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

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

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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