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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 Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.
Job Responsibilities and Essential Duties
- Lead cross-functional project teams in support of Class I - III medical devices.
- Monitor and maintain awareness of new and current product regulations and standards.
- Develop and release all project-related deliverables, including project plan, schedule and budget.
- Manage a project within standardized methods and project models such as Waterfall or Agile
- Lead and support execution of technical and/or cross-functional project work
- Ensure the timely release of critical deliverables within the project.
- Ensure all aspects of the project are in compliance to internal procedures.
- Develop and present periodic status reports.
- Effective communication with project stakeholders, local management, and global management
- Demonstrate leadership when facing uncertainty.
- Understanding of group dynamics to influence team members and lead the project.
- Instill confidence through leadership and actions.
- Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
Minimum Requirements
- BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
- Minimum of 3+ years in project lead role or project management role
- Preferred - experience in medical device or other regulated industry.
- Domestic and/or international travel up to 20%
Required Knowledge, Skills and Abilities
- Experience with Microsoft Project, JIRA, Antura or other project management software
- Experience in leading tasks/projects through a structured, phase-gate process
- Lead and manage technical meetings with cross-functional members.
- Excellent interpersonal, verbal, and written communication skills
- Strong technical writing skills; must be well organized, detail oriented.
- Task oriented and driven to complete assignments on schedule.
- Must have the ability to effectively interface with both technical and non-technical personnel.
- Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
- Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
Salary range: $120k - $140k
#LI-LG1
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.
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.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.
Job Summary:
This position is to provide organ screening support for Paragonix transplant partners. Coordinators will screen, manage, and present donor offers from the OPTN provider to the appropriately designated physician or their designee per OPTN guidelines, and with adherence to all Paragonix/ Transplant Advocate policies and protocols.Coordinators will also take part in hospital EMR documentation as well as interact with recipient patients as prescribed in the designated protocol.
Essential Functions:
- Responsible for screening offers from the OPTN contractor in accordance with transplant center criteria and OPTN policy within their designated assignment.
- Maintaining necessary training and credentials for hospital, Paragonix, and OPTN computer systems.
- Excellent customer service and communication skills with both internal and external staff including relaying clear, concise, and pertinent clinical information.
- Responsible for being reachable within 5 minutes by telephone during their 24-hour call shift. Expert knowledge on usability of all Paragonix devices
- Responsible for working in collaboration with the rest of the team to train and evaluate new members.
- Excellent customer service and communication skills with transplant center recipients and family members.
- Appropriate pre and post transplant documentation within hospital EMR and the OPTN contractor computer system.
Minimum Qualifications:
- Bachelor's degree in health science, nursing, general science, or equivalent experience in transplant related field.
- 3 years experience in clinical transplant related field
Preferred Qualifications
- ABTC certification as a CCRN or CPTC
#LI-YA2 #LI-Remote
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.
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 Responsibilities and Essential Duties
- Lead and govern design-related CAPA activities across the R&D organization, ensuring timely, compliant, and effective resolution of complex design, verification, validation, and product performance issues.
- Oversee and review root cause investigations using rigorous, data-driven problem-solving methodologies, and ensure corrective and preventive actions are appropriately scoped, risk-based, sustainable, and effectively linked to design controls, risk management, and product lifecycle processes.
- Ensure CAPA records and documentation are complete, accurate, and audit-ready, in compliance with FDA regulations, ISO 13485, and internal quality system requirements.
- Manage and develop the R&D CAPA team, including setting expectations, prioritizing
- workload, providing technical direction, and coaching CAPA specialists and engineers.
- Provide technical guidance, coaching, and mentorship to R&D engineers and CAPA owners on CAPA processes, best practices, timeline development, SOP adherence, and effectiveness verification planning.
- Serve as the primary R&D CAPA interface with Quality, Regulatory Affairs, Operations, and other cross-functional partners to address systemic and cross-product issues.
- Review and approve CAPA plans, timelines, effectiveness verification strategies, and closure rationales to ensure regulatory robustness and high-quality outcomes.
- Support internal and external audits, inspections, and assessments by providing CAPA documentation (e.g., CAPA storyboards), investigation rationale, and subject matter expertise.
- Act as a CAPA subject matter expert within the R&D organization, driving continuous improvement in CAPA execution quality and consistency.
Minimum Requirements
- Bachelor's degree in Engineering or related technical field; advanced degree preferred.
- 6+ years of experience in R&D within a medical device organization with at least 5 years of CAPA processes and regulatory compliance requirements (FDA, ISO 13485).
- 2+ years of leadership experience managing engineering teams.
- Proven experience in managing CAPA for design and development activities
Required Knowledge, Skills and Abilities
- Expert-level understanding of CAPA methodologies, root cause analysis tools (Fishbone, 5 Whys, FMEA), and risk management.
- Strong leadership and team management skills with ability to influence and drive accountability.
- Excellent analytical and problem-solving abilities with attention to detail.
- Effective communication and presentation skills for all organizational levels.
- Experience with drafting statistically sound sampling plans & acceptance criteria for measuring Effectiveness of implemented actions.
- Proficiency in documentation and electronic CAPA systems, Trackwise preferred.
- Deep knowledge of medical device regulations and design control requirements.
Salary range: $145k - $175k
#LI-LG1
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.
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.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.
Job Summary:
This position is to assist in organ screening support for Paragonix transplant partners. Coordinators will screen, provide initial response, and notify transplant coordinators of donor offers from the OPTN provider per OPTN guidelines, and with adherence to all Paragonix/ Transplant Advocate policies and protocols.
Essential Functions:
- Responsible for initial screening of offers from the OPTN contractor in accordance with transplant center criteria and OPTN policy within their designated assignment.
- Maintaining necessary training and credentials for Paragonix and OPTN computer systems.
- Excellent customer service and communication skills with both internal and external staff including relaying clear, concise, and pertinent clinical information.
- Responsible for being reachable within 5 minutes by telephone during their 12-hour call shift.
- Excellent customer service and communication skills with transplant center recipients and family members.
- Documentation of transplant center response into the OPTN computer system in accordance with established automatic rule out criteria.
- Primary contact for OPO communication during the screening process.
Minimum Qualifications:
- High School diploma
- Established history working in high stress/ customer interacting field
Preferred Qualifications
- Bachelor's degree in health science, general science, or equivalent experience in transplant related field.
Total Compensation - $45,000 a year
#LI-JF1 #LI-Remote
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.
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.
JobOverview
The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.
Job Responsibilities and Essential Duties
Drive carbon reduction roadmap and eco-design principles.
Lead lifecycle assessments and integrate sustainability into product development.
Collaborate with suppliers on low-carbon initiatives.
Support compliance with ISO 14001, ISO 14040, and FDA standards.
Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65
Define and standardizegovernance & KPI'sacross teams.
Ensure data integrity and consistent reporting.
Build dashboards to track sustainability and performance KPIs.
Review and updategovernanceto align with evolving strategies.
MinimumRequirements
Degree in Engineering, Sustainability,Project Management,or Data&Analytics.
7+years in sustainability, governance, or regulated environments.
Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).
Strong communication, stakeholder management, and analytical skills.
PMP Certification a plus.
Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)
#LI-LG1
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.
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
Primary focus is to build product by following processes to meet production goals.
Job Responsibilities and Essential Duties
- Understands and adheres to safety policies and practices.
- Responsible for quality and adheres to manufacturing process requirements and the Getinge Corporation Quality Policy.
- Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
- Demonstrates a basic understanding of Lean Manufacturing and related principles
- Maintains accurate records, including training files and shop floor paperwork (SFP).
- Willing to participate in Shared Leadership tasks and responsibilities as directed.
- Understands and follows all Getinge and site-specific policies and procedures.
- Responsible for attending and passing all required Getinge and site-specific training (i.e., QS Basics, Lean Training).
- Demonstrate an understanding of the basic functions of SAP, if applicable.
- Responsible for maintaining individual training records.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- High School diploma (equivalent) or 3 years of work experience preferred.
- Minimum experience is 0-12 months in a medical device-manufacturing environment.
Required Knowledge, Skills and Abilities
- Demonstrated ability to follow processes and has a moderate understanding of the technical job duties.
- Able to use and understand Basic English communication both written and spoken; demonstrate basic reading, writing and math skills.
- Must demonstrate ability to work effectively in a team setting, be flexible, and exhibit a willingness to learn/ take on new tasks.
The compensation range for this position is between $18.50-$19.00 per hour depending on experience and location
#LI-MV1
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.
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
To assemble components per manufacturing work instructions that meet production efficiencies and quality requirements.
Job Responsibilities and Essential Duties
- Ability to perform low-moderate assembly process.
- Ability to follow written and verbal instructions.
- Ability to perform tasks at established manufacturing standards.Demonstrate attention to detail and the ability to interface with team members.
- Demonstrate good manufacturing practices including recordkeeping.
- Operate in a clean room environment.
- Maintains safe, clean and healthy work environment by following and enforcing standards and procedures; complying with legal regulations.
- Work in a fast-paced environment constructing various components.
- Perform other related duties as required.
Minimum Requirements
- High School Diploma or equivalent.
- Basic computer skills with MS Office applications (Word/Excel) preferred.
- Ability to read, understand and comprehend directions - written and verbal (English).
- Must be able to work 1st shift (6:20AM - 2:50PM)
- Must be open to workig in a cleanroom environment
Required Knowledge, Skills and Abilities
- Must have a high commitment to safety.
- Able to pay close attention to detail.
- Must have good judgment, positive attitude and a high level of initiative.
- Good communication skills, both written and spoken.
- Good finger and hand dexterity.
- Capable of working in a fast paced, dynamic environment.
Environmental/Safety/Physical Work Conditions
- Duties are performed in a manufacturing/clean room environment.
- Personal protective equipment may be required as dictated by work environment.
- Must have the ability to work while standing for long periods of time.
- Use/work in the immediate divinity of 70/30 isopropyl alcohol (IPA) solution used for the preparation of work areas (line clearance) and used during the manufacturing process.
- May require lifting between 10-30lbs.
- Operations may be repetitive in nature and require use of force.
- May require operation of machinery equipment
- May require use of microscopes
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Pay rate: $20.50/hr
#LI-BS1
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.
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
Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to the operation of the production area, and ensure compliance with GMP, GDP, ISO, ESD, and all other regulatory requirements.
Job Responsibilities and Essential Duties
- Understand and adhere to safety policies and practices
- Understands and follows all Getinge and site-specific policies and procedures.
- Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
- Demonstrated ability to follow and implement GMP, GDP, ESD and all other applicable regulatory requirements
- Full understanding of document control procedures
- Ability to use basic test and measurement equipment
- Demonstrate an understanding of the basic functions of SAP, if applicable
- Determine if components and/or assemblies meet specification and reject if necessary.
- Escalate issues to manager as necessary.
- Maintain accurate records, including shop floor paperwork (SFP)
- Ability to work independently, or as part of a group, and display a high quality of skill in both mechanical
and electronic assembly with a minimum of supervision.
Minimum Requirements
* High School diploma or equivalent, or 3+ years of work experience required.
* Medical device or other regulated manufacturing environment experience preferred but not required
* Must have basic computer skills, SAP experience a plus
* Must be able to work in a team environment
Required Knowledge, Skills, and Abilities
* Knowledge of and ability to use basic small hand tools and power tools
* Knowledge of and ability to use basic test and measurement equipment
* Must have good oral and written communication skills
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
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.
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 Sr. Engineer, Quality Operations is responsible for understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical devices.
Job Responsibilities and Essential Duties
In this role you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support to production.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving critical quality issues
- Lead process control and monitoring of CTQ parameters and specifications
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Lead the investigation, resolution and prevention of product and process non-conformances and related CAPAs
- Lead in the completion and maintenance of risk analysis
Minimum Requirements
- Bachelor's Degree in Engineering or Science, or equivalent work experience.
- A minimum of 5-6 years of Quality Management Systems (QMS) experience.
Required Knowledge, Skills and Abilities
- Good analytical and problem-solving skills.
- High level of attention to detail and accuracy.
- Strong computer skills, including MS Office applications and statistical software are required.
- 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 FDA requirements
Supervision/ManagementOfOthers:
- Sr. Engineer, Quality Operations will help to mentor more junior engineers.
Internal and External Contacts/Relationships
- Sr. Engineer, Quality Operations position works closely with Operations, Manufacturing Engineering, Maintenance, Quality Compliance, Supplier Quality, and Continuous Improvement.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
- Office or production environment
- May work extended hours during peak business cycles.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
$95K-120K with 10% STIP
#LI-YA2 #LI-Onsite
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.
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 Sr. 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 problemsolving 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.
- Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
Salary Range: $115k - $140k
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.
