Engineering Structures Journal Jobs in Roseland, NJ
194 positions found
Engineering Project Managers
Travel: 80% (US-based)
Openings: 5
Pay Rate: $50-60/hr.+
Payment Schedule: Weekly
Benefits: Medical, dental, vision
Start Date: 2 weeks
Interview Process: 1 virtual
Duration: 6-month contract, likely extensions
Must Haves
- 4+ years experience within project management relevant to facilities (controls, industrial or electrical)
- Experience managing a high volume of projects with quick turn around
- Strong organizational skills relevant to tracking project timelines, budgets, etc.
- Cross functional collaboration skills to effectively drive progress
- Technology adept
- Adaptable to change and innovation
Plusses
- PMP
- Bachelor's degree specific to engineering
- Experience with conveyor systems
A client of Insight Global in the retail/technology industry is seeking Project Managers to assist with an initiative to update, upgrade & improve their facilities across the country. This will include general building updates as well as the upgrading of manual systems in warehouses & delivery centers, to automated systems. The goal is to improve operational efficiency within the locations make processes faster, safer and more efficient. We are looking for hands on project managers with relevant backgrounds to engineering, facilities, warehouse and maintenance related work who aren't afraid to get super involved and can direct and oversee the work being done to ensure timely and accurate completion. This is a fast paced role and requires a high level of organization skills to appropriately communicate with internal and external stakeholders about project timelines, budgets and any escalations that may arise. This person will be responsible for tracking projects in relevant software and updating playbooks accordingly as tasks are completed. This person will be in the field 80-100% of the time, executing on projects and will often be working odd hours or an occasional weekend to complete the work. Travel will primarily be regionally based, but could involve travel outside of the assigned region. Projects will focus on general building upgrades and increase in complexity as trust is earned. All travel time is paid and expenses are reimbursed but will be fronted on a personal credit card. A credit card limit of $6,000 or higher is required to appropriately support the travel, but expenses can be submitted weekly for reimbursement. We are seeking individuals within 30 minutes of a major airport in OH, IN, MI & KS.
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.
Job Title: Senior Director – Electrical Engineering
Location: Union, NJ (Hybrid)
Job Timings: Full-time, Onsite
Reports To: Executive Leadership (CEO / COO)
Role Summary
The Senior Director of Electrical Engineering provides strategic, technical, and people leadership across low- and medium-voltage electrical engineering. This role owns engineering standards, design quality, technical risk management, and capability development, while scaling teams and processes to support growth, speed, and margin improvement.
Key Responsibilities
Strategy & Leadership
- Set and execute the electrical engineering strategy aligned with business growth, ISO 9001, and product roadmap
- Lead, mentor, and scale a high-performing team of senior, mid-level, and junior engineers
- Establish succession planning, skills development, and technical career paths
Technical Excellence
- Own engineering standards, design practices, and technical governance for LV and MV systems
- Ensure compliance with NEC, IEEE, UL, IEC, ANSI, and customer specifications
- Serve as the final technical authority for complex or high-risk projects
Delivery & Execution
- Partner with Sales, Project Management, Manufacturing, and Supply Chain to deliver projects on time and on margin
- Drive design-for-manufacturability, standardization, and modularization
- Review and approve critical designs, calculations, and deviations
Process & Systems
- Build scalable engineering processes aligned with ISO 9001 and Lean principles
- Leverage ERP, PLM, and digital tools to improve design cycle time and data integrity
- Establish KPIs for quality, rework, cycle time, and engineering utilization
Innovation & Growth
- Lead new product development and technology adoption (e.g., MV gear, E-Houses, Sheltered Aisles)
- Support technical sales, key customer engagements, and strategic pursuits
- Evaluate emerging technologies and vendors to maintain competitive advantage
Qualifications
Education & Experience
- Bachelor’s degree in Electrical Engineering (Master’s preferred)
- 15+ years of progressive electrical engineering experience in power distribution or switchgear
- 7+ years in senior technical leadership or people management roles
Technical Expertise
- Deep expertise in LV and MV power distribution systems
- Strong knowledge of codes, standards, and certification processes
- Proven experience leading complex, multi-million-dollar projects
Leadership & Business Acumen
- Strong communicator with the ability to translate technical complexity into business impact
- Experience operating in fast-paced, manufacturing-driven environments
- Track record of building teams, improving processes, and delivering results
Success Metrics (First 12–18 Months)
- Improved design cycle time and first-pass quality
- Clear engineering standards and governance in place
- Strong bench of engineering leaders and successors
- Successful delivery of strategic products and complex projects
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: Remote
Duration: 12 Months (Possibility of extension)
Job Description:
Your Team & Role As an Infrastructure Security Engineer for the Global Technology Workforce Identity and Access Management (IAM) Team, you will partner with technology leads and engineers to develop and improve IAM solutions. You will design, test, and engineer new and existing solutions and streamline our day-to-day workflows, and help the Identity engineering team to meet project timelines and complete net new business as usual (BAU) work. The work will be around Security and Engineering of our Tier Zero Identity platform and Active Directory Domain Services (AD DS) systems.
Here is What You Can Expect on a Typical Day:
- Develop high quality, well documented engineering configuration and infrastructure solutions that adhere to all applicable clients security standards
- Ensure product and infrastructure security is maintained throughout the system lifecycle, integrating new security features, patches, and updates into existing environments
- Collaborate with tech leads in understanding system requirements, defining stories, creation of technical designs, and deployment of solutions
- Support engineering and other team members to understand systems end-to-end and deliver robust solutions that support positive business impact
- Write scripts and automation code to support areas such as operational excellence, production validation, and security for our Windows servers and identity infrastructure platform
- Research problems discovered internally or by stakeholders and consumers, ideate and develop solutions to mitigate without negative impact to the business
- Bring an applied understanding of relevant and emerging technologies, begin to identify opportunities to provide input to the team and coach others, and embed learning and innovation in the day-to-day
- Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
- Use programming languages including but not limited to PowerShell, Terraform, ARM templates, etc.
The work requires a minimum of 5-8 years of experience in the following areas:
- Infrastructure: Hyper-V and Windows Server Operating systems
- Observability: System Center Operations Manager (SCOM) / Azure Monitoring
- Configuration: System Center Configuration Manager (SCCM) / Azure Arc
- Identity: Active Directory Domain Services (AD DS) / Microsoft Entra ID
- Automation: PowerShell, Infrastructure and Configuration as Code (e.g. Chef, Ansible)
- Databases: SQL Server
Experience in:
Triaging and troubleshooting identity and infrastructure issues
Development of Automation and Deployments for Hyper-V and Windows Server Infrastructure
Automated testing and validation to support non-production and production changes
Writing clear engineering and system documentation (e.g. in Confluence)
Position: Senior Semantic Engineer / Ontology Engineer
Location: East Hanover, NJ (Hybrid - 3x/week onsite)
Duration: 6 Months (extendable)
DESCRIPTION:
We are hiring a Senior Semantic Engineer / Ontology Engineer to lead the design of healthcare-grade ontologies and semantic layers that power trusted analytics, interoperable data products, and AI-ready knowledge systems. You will apply metrics-first semantic modeling and ontology engineering practices aligned to the principles such as clear semantics, reusable meaning, governance-by-design, and measurable business outcomes. You'll work across RDF and property graph paradigms and Snowflake semantic layer.
Key Responsibilities:
• Design and evolve healthcare ontologies and semantic models to standardize meaning across domains (clinical, patient, provider, claims, access, quality, outcomes).
• Design data products that are AI-ready and leverage ontologies and semantic models
Build metrics-first semantic layers:
• Define canonical metric definitions, dimensions, hierarchies, and calculation rules.
• Ensure metrics are explainable, auditable, and consistently implemented across products and teams.
• Model knowledge in both RDF (RDFS/OWL) for formal semantics and interoperability.
• Property graphs for traversal-heavy use cases and relationship analytics.
Develop and maintain semantic artifacts:
• Concept schemes, entity models, vocabularies, mappings, and documentation.
• Alignment patterns between ontologies, data products, and downstream analytics/AI use cases.
Implement semantic integration patterns:
• Entity identity resolution, entity linking, terminology harmonization, and enrichment workflows.
Partner with platform teams to operationalize semantics in Snowflake:
• Enable semantic access patterns that support analytics and AI applications.
• Contribute to solutions that leverage Snowflake Cortex for semantic enrichment and assisted discovery (within established governance constraints).
Collaborate with governance and architecture stakeholders to embed:
• Versioning, stewardship workflows, quality checks, and change management for semantic assets.
• Guide best practices and mentor engineers/analysts on ontology engineering, graph modeling, and metrics-first design.
Required Qualifications
• 8+ years in semantic engineering, ontology engineering, knowledge graph development, or closely related roles.
• Demonstrated experience in healthcare data domains (payer/provider, clinical, claims, RWE, quality, outcomes, etc.).
• Strong hands-on ontology engineering experience: RDF, RDFS, OWL, SPARQL and/or graph query experience
• Ontology modularization, alignment, and lifecycle management
• Experience with property graph modeling (e.g., Neo4j-style patterns) and translating between RDF and property graph representations when needed.
• Proven delivery of a metrics-first approach:
• Canonical KPIs/metrics definitions, dimensional modeling alignment, semantic consistency across BI and data products.
• Experience working with modern cloud data platforms, especially Snowflake, and exposure to Snowflake Cortex for AI-enabled workflows.
• Strong stakeholder communication skills: able to translate clinical/business intent into precise semantic definitions and usable artifacts.
Preferred Qualifications
• Familiarity with healthcare interoperability and terminology standards (e.g., HL7/FHIR, SNOMED CT, LOINC, ICD-10) and how to map/align them to enterprise semantics.
• Experience with semantic tooling and practices, validation rules, ontology testing, and CI/CD for semantic assets.
• Experience deploying semantic context layers
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 Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates crossfunctionally to support timely resolution of product issues and support corrective and preventive actions.
Job Responsibilities and Essential Duties
- Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
- Initiate, own and support Corrective and/or Preventive Actions
- Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
- This is not an inclusive list of job responsibilities
Required Knowledge, Skills and Abilities
- Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
- Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
- General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
- Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
- Experienced with handling Biohazard materials.
- Experience with laboratory work in the medical devices industry.
- Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
- Excellent written and verbal communication skills.
- Strong problem-solving skills and a passion for investigation and root cause analysis
- Strong interpersonal skills.
- Good organizational skills. Must be able to adhere to timelines.
- Basic understanding of statistical analysis.
- Basic understanding of quality systems
The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 8% Annual Bonus
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.
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 Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
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.
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.
