Engineering Structures Jobs No Experience Jobs in Wyckoff
423 positions found
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.
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Fleet Information
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Job ID: 410058
Practice area:- Employment Law - Traditional Labor Law (Unions),ERISA/Executive Compensation - Litigation - Plaintiffs,Litigation - Appellate
Senior Labor & Employment Litigation Associate Attorney (8–10 Years Experience) – Federal Court & Appellate Work | New Jersey
Keywords:- Labor and Employment Litigation Attorney, ERISA Litigation Attorney, Union Litigation Associate Attorney, Federal Litigation Associate, Litigation Attorney New Jersey, New Jersey legal jobs, Attorney jobs NJ, NJ Bar required, Law firm litigation associate, Partner-track position, lawyer,municipal contracts,zoning ordinance,policy review,city employment law
The head office is located in New Jersey. The law practice employs eighty highly-proficient attorneys. They represent clients throughout the U.S. There are twenty-one varied practice areas. A number of their practice disciplines consist of banking, corporate law, healthcare, litigation and public finance. Practice areas are broad in scope as well. Attorneys were named in a leading industry periodical.
A leading litigation-focused law firm is seeking a Senior Labor & Employment Litigation Associate Attorney (8–10 years experience) to join its expanding practice in New Jersey. This role offers significant federal court litigation, appellate advocacy, and union-related employment matters within a growing litigation team.
________________________________________
A respected and rapidly expanding litigation practice is seeking an experienced Labor and Employment Litigation Attorney to support its growing caseload in New Jersey legal jobs involving union representation, ERISA disputes, and federal court litigation. This role is ideal for a senior Litigation Associate Attorney with a strong background in complex civil litigation, motion practice, and appellate briefing.
The firm represents clients across multiple industries and maintains a strong national presence, providing attorneys the opportunity to engage in complex labor and employment disputes while collaborating with experienced litigators. Attorneys working in this partner-track position will gain exposure to federal litigation strategy, appellate advocacy, and high-impact employment disputes.
This opportunity is actively interviewing attorneys seeking advanced New Jersey legal jobs with meaningful courtroom experience and leadership opportunities within a sophisticated litigation practice.
________________________________________
Key Responsibilities
• Lead litigation strategy and trial preparation in federal court employment and labor disputes.
• Manage discovery phases and motion practice for union-related employment litigation.
• Draft and file appellate briefs, dispositive motions, and amicus briefs.
• Conduct advanced legal research and prepare persuasive litigation arguments.
• Coordinate litigation teams and manage multiple complex cases simultaneously.
• Advise clients on developments in labor law, ERISA disputes, and litigation strategy.
• Monitor legal developments and prepare client alerts and litigation updates.
• Collaborate closely with partners and other litigators on complex litigation matters.
________________________________________
Qualifications
• 8–10 years of experience as a Litigation Associate Attorney in federal court litigation.
• Strong experience in labor and employment litigation, particularly union matters.
• Demonstrated background in ERISA and employee benefits litigation.
• Proven ability to manage complex litigation and oversee case strategy.
• Strong legal writing, motion practice, and appellate advocacy experience.
• New Jersey Bar required and active license to practice law in the state.
• Exceptional analytical thinking and litigation management skills.
________________________________________
Education
• Juris Doctor (JD) from an accredited law school.
________________________________________
Certifications
• Licensed to practice law in New Jersey.
________________________________________
Core Skills
• Advanced motion practice and federal litigation experience.
• Exceptional legal writing and appellate brief drafting skills.
• Strong courtroom advocacy and oral argument abilities.
• Experience managing discovery and complex case dockets.
• Ability to handle multiple high-stakes litigation matters simultaneously.
• Strategic thinking and client advisory capabilities.
________________________________________
Culture & Firm Appeal
This opportunity is with a well-established litigation practice headquartered in New Jersey that represents clients nationwide. The firm maintains a collaborative legal environment with attorneys practicing across more than twenty legal disciplines.
Attorneys benefit from a broad litigation platform supporting work across industries including finance, healthcare, corporate services, and complex civil litigation matters. The firm is known for its experienced attorneys, strong litigation reputation, and recognition in respected legal industry publications.
Professionals exploring New Jersey legal jobs will find a collaborative legal team environment with strong mentorship, high-level case exposure, and meaningful career advancement opportunities within a sophisticated litigation practice.
________________________________________
Why This Role Is Unique
• Opportunity to handle federal court litigation and appellate advocacy.
• Direct involvement in labor union litigation and ERISA disputes.
• Exposure to complex civil litigation with significant courtroom responsibilities.
• Work alongside experienced litigators in a nationally recognized practice.
• Clear partner-track position offering leadership and advancement potential.
• Ideal opportunity for attorneys seeking senior New Jersey legal jobs in litigation.
This position rarely opens at this level and provides a strong opportunity for experienced litigators to take on a leadership role within a respected litigation practice.
________________________________________
Benefits
• Comprehensive health insurance.
• Retirement savings plan.
• Professional development opportunities.
________________________________________
Call to Action
Apply now for a confidential discussion with a BCG Attorney Search recruiter.
Explore this elite-level opportunity today.
Submit your resume to learn more about this prestigious role.
________________________________________
BCG Attorney Search is the industry leader for placing candidates in permanent positions in law firms. Since 2000, our recruiters have placed several thousand attorneys and enjoyed extraordinarily high success rates with our candidates. As a BCG Attorney Search candidate, you have access to more opportunities than any legal placement firm in the United States. We are able to offer the most in-depth insight in the legal recruiting market thanks to our dedicated team of over 150 employees who mercilessly research, study and analyze the legal market. The depth and breadth of our research empowers us to place attorneys at rates that are unparalleled at any placement firm in the United States. Many of our recruiters make 30 to 40 placements per year, while recruiters at competitor firms are likely to make four or five. Unlike other placement firms that can only tell you about openings at major AmLaw firms, we place candidates of all backgrounds in firms of all sizes. While other legal recruiters only represent a narrow band of candidates from top law firms and top law schools, our research, firm contacts, and market insight allow us to place hundreds of candidates each year who do not fit this mold. It is rare that we do not get candidates we represent interviews and offers. No one in the world is better at legal recruiting and placement than BCG Attorney Search.
BCG Attorney Search will confidentially review your application and will not forward your materials to the firm without first discussing the opportunity with you.
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
This is a defined term/fixed term position for one year with a potential to convert to regular hire at the end of the year.
The People Experience Specialist is a key member of the People Experience team responsible for delivering a simple, human, and helpful HR experience. This role supports employees, managers, and HR Business Partners by responding to inquiries related to benefits, payroll, disability and leave management, and HRIS and reporting. In addition to daily support through the HR Helpline (walk in's, email, phone, and system requests), the People Experience Specialist contributes to our digital transformation by promoting selfservice tools, leveraging AIenabled solutions, and identifying opportunities to streamline and improve HR processes. This role blends operational excellence with a humancentric approach to ensure all stakeholders receive timely, accurate, and empathetic support.
Job Responsibilities and Essential Duties
- Serve as the first-line contact for employees, managers, and HR Business Partners on questions related to benefits, payroll, disability and leave management, HR policies, and general employment inquiries through email, phone, and case management systems.
- Manage daytoday HR operations, including digital onboarding workflows, employee lifecycle transactions (new hires, terminations, transfers, compensation and personal changes), and documentation while ensuring accuracy, compliance, and a positive employee experience.
- Leverage technology, automation, and AIenabled tools to streamline routine processes, promote selfservice, and improve response times while maintaining human touchpoints for critical or sensitive moments.
- Conduct selfaudits and peer reviews to ensure data integrity, compliance, and adherence to established procedures, resolving discrepancies as needed.
- Support benefits administration, including enrollments, invoice reconciliation, data audits, and coordination with thirdparty vendors for leaves of absence and background screening processes.
- Generate and distribute recurring and adhoc HR reports (e.g., employee changes, timeoff reports, overtime, pay calculations) to support business needs and data-driven decision-making.
- Contribute to ongoing enhancements in People Experience by identifying opportunities for process improvement.
- Participate in policy simplification efforts and support knowledge management through improved documentation and self-service content.
- Support the deployment of HR projects and initiatives in collaboration with People & Culture Partners and Global People Processes teams, ensuring local alignment and smooth implementation.
- Perform additional responsibilities as needed to support organizational development and evolution, as discussed during the Performance Development Process (PDP).
Required Knowledge, Skills and Abilities
- Associates' Degree or equivalent combination of education and relevant work experience.
- A minimum of 3 years relevant experience within a Human Resources, and/or Employee Service Center or a Customer Service environment.
- Experience with HRIS Systems such as UKG and Success Factors products preferred.
- Basic knowledge and understanding of benefit plans and administration required.
- Basic knowledge of payroll, understanding of check details deductions, pay calculations is required.
- Skilled in using HR digital tools such as AI
- Must be customer-focused and detail oriented. Demonstrated ability to provide a high level of responsiveness and customer attention and service.
- Strong attention to detail.
- Proactive and solution-oriented individual that works well in a team environment.
- Strong verbal and written communication skills and ability to maintain confidentiality of human resources information and actions.
- Strong Microsoft Office skills, including Word, Excel and PowerPoint
Salary range: $37-$38.50/hr
#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 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.
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Participants are needed on a wide range of topics such as:
- Health Issues (Research for cures and new medications to treat ailments)
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- Internet Usage (How you use the internet)
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- Employment (Various types of jobs or career fields)
- Food & Beverages (the consumption of various foods and beverages)
- Entertainment (About TV, movies or video games)
- Social Media (the use of different social media platforms)
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- Gender (studies based on your gender)
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Compensation:
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Benefits:
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- You get to review and use new products or services before they are launched to the public.
Qualifications:
- Speak and/or read English
- Must be 18yrs old or older
- Must have either a phone, computer or tablet with internet connection
Experience:
- Start Immediately - No Experience Needed! Anyone Can Participate!
Education:
- Open to all education levels - Your opinion matters!
Remote working/work at home options are available for this role.
Want to make extra money on YOUR schedule? Join our exclusive list of research study participants and start earning extra income today!
Perfect for anyone seeking remote, part-time, or temporary work, these opportunities require no previous experience and offer unmatched flexibility. Choose the studies that suit you best—whether online, in-person, or over the phone—and get paid for sharing your opinions.
Don't miss out on this chance to turn your free time into valuable earnings!
Participants are needed on a wide range of topics such as:
- Health Issues (Research for cures and new medications to treat ailments)
- Consumer Products (Your experience with consumer products)
- Shopping (Shopping experiences)
- Internet Usage (How you use the internet)
- Vehicles (recreational vehicles and automobiles)
- Employment (Various types of jobs or career fields)
- Food & Beverages (the consumption of various foods and beverages)
- Entertainment (About TV, movies or video games)
- Social Media (the use of different social media platforms)
- Financial (Banking and investing)
- Retirement (Planning what, when and how)
- Gender (studies based on your gender)
- Housing (Renters or Homeowners)
Compensation:
- Earn up to $250+ in Just ONE Hour! (Focus Group Session)
- Earn up to $3,000+ (Multi-Session Studies)
Benefits:
- Flexibility to take part in discussions online or in-person.
- No commute needed if you choose to work from home.
- No minimum hours. You can do this part-time or full-time
- Enjoy free samples from our sponsors and partners in exchange for your honest feedback of their products.
- You get to review and use new products or services before they are launched to the public.
Qualifications:
- Speak and/or read English
- Must be 18yrs old or older
- Must have either a phone, computer or tablet with internet connection
Experience:
- Start Immediately - No Experience Needed! Anyone Can Participate!
Education:
- Open to all education levels - Your opinion matters!
Remote working/work at home options are available for this role.
Company: QuickWash Technologies, Inc
Location: Remote
Employment Type: Full-Time
QuickWash is a technology platform that connects businesses and their employees with convenient on-site car washing and detailing services. Our mission is to simplify vehicle care by bringing professional detailing directly to workplaces and residential communities.
We are currently expanding and looking for a driven Corporate Account Executive to help grow our corporate partnerships and bring QuickWash services to new companies.
The Corporate Account Executive will be responsible for developing new corporate relationships and introducing businesses to QuickWash as an employee perk and workplace amenity. This role focuses on setting up pilot service days and converting those pilots into long-term corporate contracts.
This role is ideal for someone who is ambitious, competitive, and looking to grow into a strong sales and business development career. No prior experience is required for the right candidate.
- $30,000 Base Salary
- 6% of gross revenue generated from contracts you close
- 3% recurring commission on revenue after the first 12 months upon renewal
- Once $2,000,000 ACR (Annual Contract Revenue) is hit, Base Salary Goes to $60,000
- Or
- No Base Salary
- 10% of gross revenue generated from contracts you close
- 5% recurring commission on revenue after the first 12 months upon renewal
- Once $2,000,000 ACR (Annual Contract Revenue) is hit, splits increase to 12% & 8%
- Prospect and reach out to businesses to introduce QuickWash services
- Schedule and coordinate pilot service days for prospective corporate partners
- Convert pilot days into long-term corporate contracts
- Build relationships with office managers, HR teams, and decision-makers
- Track outreach, pilots, and conversions through the company CRM
- Work closely with the QuickWash operations team to ensure successful service days
- Set up 20 pilot service days per month
- Convert 10 pilot locations into long-term corporate contracts per month
- Each corporate contract is estimated to generate approximately $1,000 per month in recurring revenue
While no experience is required, the following experience is helpful:
- Sales or business development
- Cold calling or outbound outreach
- Account management or client relationship management
- Startup or fast-growing company environments
- Highly motivated and competitive
- Strong communication skills
- Comfortable speaking with business decision-makers
- Organized and able to manage multiple prospects simultaneously
- Entrepreneurial mindset with a desire to grow with the company
- Opportunity to grow with a fast-growing tech platform
- Unlimited commission potential
- Flexible remote work environment
- Ability to play a key role in the company’s expansion
- Path to earning six figures within 3 years for top performers
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.