Jobs in Wayne, NJ
551 positions found — Page 22
This Jobot Job is hosted by: Kirk Morgan
Are you a fit? Easy Apply now by clicking the "Apply" button
and sending us your resume.
Salary: $120,000 - $150,000 per year
A bit about us:
A growing defense contractor.
Why join us?
Fantastic benefits, 401K, and PTO plan.
Job Details
Job Details:
We are currently seeking a highly skilled and motivated Permanent Systems Engineer to join our dynamic team. This is an exciting opportunity to work in a fast-paced environment in the Engineering industry, focusing on defense industry projects. The successful candidate will be responsible for overseeing the entire life cycle of system development and implementation, providing technical guidance to the engineering team, and ensuring all projects meet defense industry standards. This role requires a deep understanding of interface control documents, DoD Defense planning manufacturing, VCRM, functional analysis, and the ability to translate requirements into hardware and software specifications. The ability to solve complex problems is a must.
Responsibilities:
1. Oversee the entire life cycle of system development and implementation, ensuring all projects are completed on time and within budget.
2. Provide technical guidance and mentorship to the engineering team, fostering a culture of continuous learning and improvement.
3. Ensure all projects adhere to defense industry standards and best practices.
4. Develop and maintain interface control documents, utilizing your expertise in DoD Defense planning manufacturing and VCRM.
5. Conduct functional analysis and translate requirements into hardware and software specifications, ensuring all system components meet the needs of the end-user.
6. Solve complex problems, utilizing your analytical skills to identify the root cause of issues and develop effective solutions.
7. Collaborate with cross-functional teams, including manufacturing and quality assurance, to ensure the successful delivery of projects.
Qualifications:
1. Bachelor's degree in Engineering, Computer Science, or a related field.
2. Minimum of 5 years of experience in the Engineering industry, with a focus on the defense sector.
3. Extensive experience with interface control documents, DoD Defense planning manufacturing, and VCRM.
4. Proven track record in system development and implementation.
5. Exceptional problem-solving skills, with the ability to think critically and develop effective solutions to complex challenges.
6. Strong knowledge of defense industry standards and best practices.
7. Excellent communication skills, with the ability to provide technical guidance and mentorship to a team.
8. Experience in functional analysis and translating requirements into hardware and software specifications.
9. Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
10. Must be a team player, with a commitment to continuous learning and improvement.
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: /privacy-policy
This Jobot Consulting Job is hosted by: Stefan Woods
Are you a fit? Easy Apply now by clicking the "Apply" button
and sending us your resume.
Salary: $55,000 - $68,000 per year
A bit about us:
A national real estate development and construction comprised of comprised of planning, architecture, design, construction, marketing, and resident experience professionals
Why join us?
Our core values shape our culture and provide direction for everything we do
Job Details
We are seeking a highly organized and detail-oriented Office Coordinator to join our team. The ideal candidate will play a key role in ensuring the smooth day-to-day operations of the office, supporting administrative functions, and maintaining a positive and efficient work environment. This position requires strong communication skills, multitasking ability, and a proactive approach to problem-solving.
Key Responsibilities:
- Serve as the first point of contact for visitors and staff; manage front desk and phone coverage
- Coordinate office operations and procedures to ensure organizational effectiveness and efficiency
- Manage office supplies inventory and place orders as necessary
- Schedule and coordinate meetings, appointments, and travel arrangements
- Maintain and organize physical and digital files and records
- Assist with onboarding new employees and coordinate workspace setups
- Liaise with facility management, vendors, and service providers
- Monitor and manage office budget and petty cash (if applicable)
- Support HR, accounting, and other departments with administrative tasks as needed
- Plan and coordinate office events, meetings, and staff engagement activities
Qualifications:
- High school diploma or equivalent; Associate’s or Bachelor’s degree preferred
- 2+ years of experience in office administration, reception, or coordination roles
- Proficient in Microsoft Office Suite (Word, Excel, Outlook) and comfortable with office technology
- Excellent communication, interpersonal, and organizational skills
- Ability to work independently and handle multiple priorities in a fast-paced environment
- Strong attention to detail and problem-solving skills
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: /privacy-policy
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 primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Manager.
Job Responsibilities and Essential Duties
- 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.
Minimum Requirements
- 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.
Required Knowledge, Skills and Abilities
- 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.
Salary range: $94,000.00 - $97,000.00
#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
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.
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.
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
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. 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.
Location: Clifton NJ 07012
Duration: 6 months
Shift/Time Zone:
Sunday to Thursday 9am-5:30pm
JOB SUMMARY:
Perform the daily activities as described below. Basic Purpose: Perform various routine laboratory functions in a precise and accurate fashion to assist the laboratory professional staff and to facilitate production.
JOB REQUIREMENTS:
- Sorting, and receiving specimens in the department.
- Performs routine instrument maintenance on some equipment.
- Performs laboratory tasks of centrifuging specimens, printing extra labels, recording data (temperature charts) specimen storage and retrieval.
- Preparing reagents and or media in the department.
- Preparing specimens at workstations for testing. (Including building worklists, aliquoting specimens into sample cups, checking specimens for clots and fibrin, inoculation, slide preparation)
- Performs QA/QC duties as assigned.
- Resolves pending lists.
- Finds missing samples.
- Decontaminates work areas.
- Performs weekly radioactive wipe tests.
- Maintains files for department records.
- Changes gas cylinders.
- Follows all PPE requirements and all safety regulations.
- Uses the laboratory computer system as well as operates PCs.
- Disposes of biohazardous material.
- Completes training and competency checklists as appropriate.
- This is not an exhaustive list of all duties and responsibilities, but rather a general description of the work performed by this position.
Education:
- High school diploma or equivalent.
- Medical assistant training helpful.
- Math and science courses preferred.
Work Experience: None required
Special Requirements:
- Must have the ability to establish work priorities and to handle several tasks for maximum workstation efficiency.
- Must be able to retain information once learned.
- Must interact with other coworkers, internal and external customers with courtesy and respect.
- Key Word Search: laboratory, medical
