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Principal Automation Engineer Optical Inspection SME
Janssen Biotech, Inc. Legal Entity
Wilson, NC
Senior Automation Engineer will lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver…
Added 4 mins ago
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Principal Platform Software Engineer - Oracle Health
Oracle
United States
- $105,900 to $234,600 USD / year
Provide technical leadership across engineering initiatives, driving system design, architectural decisions, and implementation strategies for complex, scalable solutions.
Added 6 mins ago
Software Test Engineer I
Medtronic
Mounds View, MN
Medtronic is seeking a motivated and detail-oriented Software Test Engineer to join our Affera Mapping and Ablation System team. This role is essential in supporting the testing and quality…
Added 6 mins ago
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EMC Test Engineer (3rd shift and weekends) 1 1
TUV SUD America
New Brighton, MN
- $75,000 to $90,000 USD / year
As an EMC Test Engineer, you will perform electromagnetic compatibility (EMC) testing and evaluations for a wide range of products to support global regulatory compliance and certification…
Added 6 mins ago
TS
EMC Test Engineer (3rd shift and weekends) 1
TUV SUD America
New Brighton, MN
- $75,000 to $90,000 USD / year
EMC Test Engineer - Automotive & EMC Compliance
Added 6 mins ago
Senior Quality Systems Engineer
THE CLEVELAND ELECTRIC LABORATORIES COMPANY
Twinsburg, OH
CEL is seeking an experienced Senior Quality Systems Engineer to lead, maintain, and continuously improve the company's Quality Management System across its manufacturing, calibration,…
Added 6 mins ago
BM
Sr. Design Assurance Engineer
Bracco Medical Technologies
Eden Prairie, MN
- $11.41 USD / hour
-The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for…
Added 6 mins ago
Software Engineer 2 - Mobile Developer (iOS & Android)
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Added 7 mins ago
Senior Software Engineer - Incentive Compensation
Wells Fargo
MINNEAPOLIS, MN
…benefits, learning and recruiting. We are seeking a Senior Software Engineer to support Varicent Incentive Compensation configuration. The chosen individual will be responsible to analyze,…
Added 10 mins ago
Airflow Modeler – Data Center Design
Arcadis
New York, NY · San Francisco, CA · Sacramento, CA · NY
…bypass airflow, pressure distribution, hot spots, and cooling-system effectiveness, and recommend improvements to equipment layout, airflow management, and cooling…
Added 13 mins ago
Sr Advanced Software Engineer
Brady Corporation
Charlotte, NC
As a Sr Advanced Software Engineer – Android OS Architect, you will help architect and develop advanced embedded Android and Linux platforms for Brady Corp connected devices and industrial…
Added 17 mins ago
Lead Night Shift Field Engineer
Bechtel Corporation
Houston, TX
…control, technical inspection and testing, and coordination of system turnover. Your work will help ensure assigned field activities are planned, executed, accurately documented, and…
Added 19 mins ago
Lead Software Integration Solutions Architect
RTX
United States
…integration practices, resolve issues, and deliver high-quality system builds. This role requires strong technical depth, hands on integration experience, and demonstrated leadership within…
Added 19 mins ago
Senior Systems Engineer
AEye, Inc
Pleasanton, CA
We are looking for a Senior Systems Engineer to join our systems engineering team and drive the requirements, system architecture, performance analysis, and functional safety work for…
Added 21 mins ago
SETA Systems Engineer (Mid)
KBR
Chantilly, VA
KBR is seeking a Systems Engineer (SETA) to support our customer. The Technical Professional (SETA) provides systems engineering and analytical support to help inform national security…
Added 21 mins ago
Principal Software Algorithm Engineer - Digital Cytology AI
Hologic
Marlborough, MA
Hologic is seeking a Principal Software Algorithm Engineer to design, train and validate deep learning models for cytology on the Genius™ Digital Diagnostics System. This role owns the…
Added 24 mins ago
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Software Test Engineer I
LivaNova
Houston, TX
- $85,000 to $100,000 USD / year
As our Software Test Engineer, you will work with a robust, cross-functional group of electrical, RF and firmware engineers.
Added 28 mins ago
OSP Engineer
Pearce Services
United States
As an OSP Engineer supporting the Ziply program at Pearce, you will lead complex outside plant (OSP) engineering projects supporting Frontier's fiber and copper telecommunications…
Added 29 mins ago
Senior Principal Test Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Defense Systems is seeking a Senior Principal System Test Engineer for the Command Systems team. This position will be located in Roy, UT and will support the Sentinel…
Added 29 mins ago
Senior Principal Test Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Defense Systems is seeking a Senior Principal Test Engineer for the AVE-IATC (TP&E) team. This position will be located in Roy, UT and will support the Sentinel (GBSD)…
Added 29 mins ago
Senior Principal Test Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Strategic Deterrent Systems division is seeking a Senior Principal Test Engineer to join our team of highly qualified and diverse individuals. This position will be located…
Added 29 mins ago
Sentinel - Principal / Sr Principal Systems Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Defense Systems is seeking a Principal / Sr Principal Systems Engineer . This opening is in Roy, UT and will support the Sentinel Program . Northrop Grumman supports the…
Added 29 mins ago
Sentinel - Sr Principal Engineer Systems
Northrop Grumman
Roy, UT
As a SEIT Verification engineer, you will be responsible for defining and coordinating the Sentinel systems engineering strategy for the allocation and verification of military and industry…
Added 29 mins ago
Sentinel - Staff Systems Safety Engineer
Northrop Grumman
Roy, UT
The Sentinel program has an exciting opportunity for a Systems Engineer to join the team supporting activities including use case development, requirements definition / allocation,…
Added 30 mins ago
ST
Systems Engineer
SUPERIOR TALENT RESOURCES, INC.
SALT LAKE CITY, UT
- $59.57 USD / hour
Description Job Title: Systems Engineer Location: Salt Lake City, UT Employment: Temp to Perm (12 months) Industry: Aerospace and Defense Compensation: $ 59.57/hr. Schedule: 40 hours /week…

Getinge

Sr. Engineer, R&D CAPA - Wayne, NJ

Wayne, NJ, United States

Salary range: $115k - $140k; 10% STIP

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Job details

Pay: Salary range: $115k - $140k; 10% STIP
Experience: 5+ years of experience in R&D engineering within a medical device organization.
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

The Senior R&D Engineer – CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.

Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.

Job Responsibilities and Essential Duties

Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
Collaborate closely with cross-functional partners - including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering - to address systemic and cross-functional issues.
Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
Serve as a technical CAPA subject matter expert within the R&D organization.

Minimum Requirements

Bachelor’s degree in Engineering or related technical discipline; advanced degree preferred.
5+ years of experience in R&D engineering within a medical device organization.
Demonstrated experience managing and executing CAPA activities within product design and development.
Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.

Required Knowledge, Skills and Abilities

Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
Strong analytical and problem‑solving skills with exceptional attention to detail.
Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
Effective verbal and written communication skills for presenting findings across all organizational levels.
Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
Proficiency with CAPA and documentation systems; TrackWise experience preferred.
In-depth knowledge of medical device regulations, design control processes, and quality system expectations.

Salary range: $115k - $140k; 10% STIP

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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More about this job

Skills

Research
Root cause analysis
Regulatory compliance
Process improvement
Problem solving
Team leadership
Coaching
Risk management
Documentation
Regulatory affairs
Inspection
Attention to detail
Communication skills
Medical device regulations

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