Engineering Jobs in Ridgewood New Jersey
50 positions found — Page 3
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
To support CS Manufacturing and support the manufacturing engineering department.
Job Responsibilities and Essential Duties
- Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
- Participates in Material Review Boards (MRB) Decision process.
- Identifies and implements corrective actions for manufacturing related issues.
- Performs equipment setup and corrective, preventative and calibration maintenance as necessary.
- Installs and validates equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
- Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
- Certifies manufacturing associates in the production processes.
- Evaluates and orders necessary equipment, tools, and fixtures.
Minimum Requirements
- A high school diploma or equivalent is required. Associate Degree in Engineering, Science or related technical field is preferred.
- One to three years of technician experience in a manufacturing environment is required; Experience working in medical device manufacturing or other FDA regulated industry would be ideal.
Required Knowledge, Skills, and Abilities
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Must demonstrate effective verbal and written communication skills.
- Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities. Must be flexible and demonstrate the ability to take initiative.
- Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
The compensation range for this position is between $26-$31 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.
Working directly with and mentored by senior managers, Senior Operations Analyst uses analytics to solve cross-functional strategic problems and drives process improvement throughout the organization. He/she will work with manufacturing, product development, merchandising, sales and installation teams to identify and root-cause major operation issues and suggest projects to improve quality, logistics, operations and customer experience. Senior Operations Analyst must have strong analytical and problem-solving skills, good communication skills and the ability to work cross-functionally with high level of self-autonomy. Growth opportunities into senior operating and leadership roles.
Key Responsibilities:
- Work with senior management to identity, analyze and solve systemic business problems
- Analyze all internal communications (plant support office, sales team, customers, etc.) to identify key issues requiring process improvement
- Evaluate operations procedures and processes
- Identify organizations inefficiencies and areas for improvement and redesign
- Root-cause and develop potential solutions to most reoccurring problems; develop and confirm hypothesis using analytics and leveraging experiences
- Communicate recommendation to key managers and leaders and push for changes needed to drive improvements
- Track and facilitate process improvements working across functional groups
- Proactively develop and maintain effective working relationships with and between all departments
- Works at the appropriate levels in the organization to implement strategies and plans
Key Requirements:
- BS/MBA from accredited university in statistics, business, operations research, industrial engineering or related fields
- 3-5 years operations
- Five to ten years of relevant experience including:
- Minimum three years as analyst in consumer, retail or manufacturing business
- Operating experience in manufacturing or consumer business
- Experience using data for root-causing cross-functional business problems
- Leadership – able to use data to influence others and drive change
- Strong skills in Microsoft Excel, Access, Tableau or similar
- Knowledge of SQL or similar software strongly preferred
- Demonstrated communication skills (written and oral)
- Deep process orientation and strong problem solver
- Able to multitask, prioritize, and manage time efficiently
- Excellent verbal and written communication skills
We will invest the necessary time to set the Senior Operations Analyst up for long-term success at BTG. Actual plan will be customized to the individual but will include time to learn the business (retail and manufacturing) and to develop the important internal relationship and trust needed to successfully grow into this leadership role.
NTG Staffing is seeking a Manufacturing Engineer for a company in Northvale, NJ. This is a direct hire opportunity. The company is seeking a candidate with specific experience in injection molding or metal stamping. Must be local to be considered.
Overview
- Responsible for designing, implementing, and optimizing manufacturing processes to improve efficiency, reduce costs, and maintain product quality.
- Uses production data analysis, process improvements, and technology implementation to support operational excellence.
- Collaborates cross-functionally with engineering, production, and quality teams to ensure successful product launches and ongoing manufacturing performance.
Key Responsibilities
- Improve manufacturing efficiency by analyzing workflows, equipment layout, and facility space utilization.
- Monitor and control manufacturing costs, including labor, materials, and production expenses.
- Identify process improvement opportunities and implement solutions to reduce waste and increase productivity.
- Develop and enforce quality control procedures to ensure products meet established standards.
- Lead pre-launch activities such as prototype, pilot, and validation builds to ensure smooth transition to full production.
- Partner with engineering, design, and production teams to achieve operational and manufacturing goals.
Core Qualifications
- Bachelor’s degree in Engineering or related technical field.
- Minimum of 3 years of Manufacturing Engineer experience.
- Automotive industry experience preferred.
- Strong analytical skills with ability to interpret production data and drive improvements.
- Proven problem-solving skills related to manufacturing processes.
- Strong organizational skills, attention to detail, and ability to meet deadlines.
Electrical Contractor located in Northern Bergen County, NJ seeking a full-time Estimator/Project Manager for commercial projects varying in size throughout the NYC and Tri-State Areas.
ROLE OVERVIEW
- Interpret job bid instructions, technical specifications, and architectural construction prints that are necessary in creating accurate electrical pricing for projects.
- Maintain and log incoming/outgoing bids and meet the deadlines for providing pricing to customers.
- Process and distribute critical/technical information and procured material to the labor force actively building projects.
- Preparation and maintenance of RFI/CO logs over the course of an active project.
- Full-time, in person role
- Work hours: 7:00am – 4:30pm
REQUIREMENTS AND QUALIFICATIONS:
- Four-year degree minimum.
- Degree in engineering/construction is a plus.
- Prior experience in the construction industry is a plus.
- Interest in the Construction and Project Management Field.
- Familiarity with Accubid, AutoCAD, and Bluebeam software is a plus.
- Strong mathematical, mechanical, and technical aptitude.
- An interest and passion for problem solving as it relates to real life construction projects.
- Organizational skills, time management, and willingness to learn are required.
- Must have good communication skills to effectively engage in project meetings with other subcontractors, general contractors, and design professionals.
- Should have strong confidence in speaking either on the phone or in person on a regular basis to vendors, customers, and labor force.
- Must be self-motivated and be able to follow through with a project/estimate from beginning to end with intensity, passion, and pride for their own work.
- Be dependable, self-motivated, and able to function independently with little supervision.
- Enjoys the challenges of an intense, creative, and fast paced industry with opportunity for self-made growth.
- Fluent in English.
- Not a fit for those with a desire to be involved with engineering/architecture design.
BENEFITS:
- Medical - Company pays 75%
- Dental – Company pays 50%
- Life – Company pays 50%
- Holidays
- Vacation
- 401k
- Profit sharing
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
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.
