Engineering Jobs in North Caldwell

Job Overview

They are seeking a highly skilled and experienced Quality Assurance Manager to lead our quality operations and ensure strict compliance quality standards. The ideal candidate will bring deep expertise in aerospace or defense manufacturing environments, with a hands-on leadership style, and a commitment to continuous improvement and regulatory compliance.

Key Responsibilities:

Lead, manage, and support quality staff in Raw Inspection, X-Ray, NDT, Final Inspection, and Shipping departments. Ensure compliance with AS9100 and NADCAP standards across all relevant quality functions. Support the First Article Inspection and PPAP process, ensuring all documentation and validation meet standards and customer requirements. Coordinate and lead internal and external audits, including customer, regulatory, and certification audits. Develop and implement quality procedures, metrics, and reporting tools to drive continuous improvement. Investigate non-conformances, lead root cause analysis, and drive effective corrective/preventive actions. Serve as a quality liaison between internal teams and external customers. Train and mentor quality staff to maintain high standards of performance and compliance. Oversee quality documentation for final product inspections and shipping to ensure full traceability and compliance.

Qualifications:

Bachelor’s degree in Engineering, Quality Management, or a related field (or equivalent industry experience). Minimum 8 years of quality leadership experience in a manufacturing environment for aerospace or defense. Proven experience with AS9100, NADCAP, and other quality standards. Strong knowledge of NDT techniques and inspection best practices. Experience managing cross-functional teams and leading audits. Strong communication, organizational, and documentation skills. Proficiency with ERP and quality management systems (QMS).

Working Conditions:

Office and manufacturing floor environment. Minimal travel may be required for audits, training, or supplier engagement

Global Trade & Duty Drawback Specialist

Onsite: Passaic County, NJ

Position Summary

The Global Trade & Duty Drawback Specialist will be responsible for coordinating, maintaining, and executing a compliant duty drawback program while maximizing duty recovery opportunities. This role will oversee the collection and analysis of import/export documentation, manage drawback claims, and ensure compliance with U.S. Customs regulations.

The position will also play a key role in identifying potential tariff reimbursement opportunities, including those resulting from recent U.S. Supreme Court decisions and regulatory developments, ensuring the company captures all eligible duty recovery opportunities.

Key Responsibilities

Duty Drawback Program Management

• Coordinate, maintain, and execute a compliant duty drawback program, including data and document collection (import, export, receiving, manufacturing, etc.) and auditing prior to claim submissions.
• Prepare and file drawback submissions and ensure timely submission of claims with appropriate documentation.
• Direct and manage the workload of the duty drawback broker, ensuring accurate and complete data is provided.
• Review company import/export activity to maximize duty recovery opportunities.
• Monitor drawback bond sufficiency and work with Customs Regulatory teams to make adjustments as required.
• Manage and document drawback refunds, ensuring accurate allocation to business units and reporting to Finance.

Trade Compliance & Tariff Strategy

• Identify opportunities for tariff reimbursement or duty recovery, including those related to recent legal and regulatory developments affecting tariffs.
• Maintain awareness of regulatory updates, court rulings, and federal policy changes impacting global trade and duty drawback programs.
• Evaluate the potential impact of South American duty structures and trade regulations on company import/export operations.

Cross-Functional Collaboration

• Drive process improvements in collaboration with Manufacturing, Accounting, and Finance to maximize refund recovery per manufactured unit.
• Coordinate with business units, Customs Regulatory teams, and duty drawback brokers regarding drawback desk reviews and regulatory inquiries (CF28s).
• Conduct feasibility analyses to determine eligibility for Duty Drawback and Foreign Trade Zones.

Documentation & Compliance

• Maintain and update Drawback Manufacturing Rulings, and prepare submissions for new activities when required.
• Maintain Standard Operating Procedures (SOPs), work instructions, templates, and documentation related to duty drawback processes.
• Provide training and guidance to internal stakeholders on duty drawback strategies, compliance requirements, and recovery opportunities.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• 5+ years of experience managing U.S. Customs Duty Drawback programs.
• Licensed Customs Broker (LCB) or Certified Customs Specialist (CCS) required.
• Strong knowledge of CFR Titles 15 and 19, including in-depth understanding of Duty Drawback regulations.
• Demonstrated experience preparing and filing drawback submissions and regulatory documentation with U.S. Customs.
• Working knowledge of international trade regulations and duties within South American markets, including import/export considerations across the region.
• Ability to identify compliance issues and propose corrective actions and process improvements.
• Hands-on experience with ERP systems (preferably SAP) and Global Trade Management software.
• Advanced proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint, Visio) with strong analytical capabilities.
• Ability to collaborate with cross-functional teams including procurement, finance, sales, logistics, order management, and engineering across multiple time zones.

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 position performs installation, maintenance, and repairs of computer driven electro-mechanical production equipment, ensuring that all related quality documentation is executed, while reviewing maintenance procedures for effectiveness.

Job Responsibilities and Essential Duties:

* Maintenance and repair of computer driven electro-mechanical manufacturing equipment in support of medical device production.

o Computer driven systems include proportional-integral-derivative (PID) operating controllers, programmable logic controllers (PLCs), and Human Machine Interface (HMI) automation.

o Sub-systems and components include electric drives, motors, electrical wiring, hydraulics, pneumatics, electrical panels, relays, printed circuit board circuitry, vacuum, and compressed air.

* Respond to emergency repair requests through troubleshooting, diagnosis, resumption of operation, and electronic documentation.

* Execute preventative/scheduled maintenance including planning of materials, parts, training, and other requirements to ensure work is executed in an efficient and timely manner.

* Document all work planned and performed in the computerized maintenance management system.

* Evaluate operation of equipment and instruments to conduct on-line adjustments. * Evaluate, quote, and order necessary replacement equipment, tools, and fixtures. * May develop or revise documents and procedures.

* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Requirements :

* A high school diploma or equivalent is required. An associate degree or equivalent years of experience in Engineering, Science or related technical field is preferred

* 1-3 years of technician experience in a manufacturing environment is required; experience working in medical device manufacturing or other FDA regulated industry preferred.

Required Knowledge, Skills, and Abilities :

* Ability to read wiring diagrams, schematics, and plumbing diagrams to expertly troubleshoot electro-mechanical equipment, electric drives, motors, basic wiring, hydraulics, and pneumatics is required.

* Working knowledge of flow controls, valve selection, and pressure regulation.

* 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.

* Working knowledge of equipment powered by 120, 208/230, and 480VAC electrical voltage is required.

* Experience with PLC/HMI and MS-DOS programming languages is preferred.

* Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.

The pay for this role is a minimum of $25 per hour ($52k/yr) and a maximum of $33 per hour ($68,640/yr).

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

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.

With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries.

Sika has subsidiaries in 102 countries around the world and, in over 400 factories, produces innovative technologies for customers worldwide. In doing so, it plays a crucial role in the transformation of the construction and transportation sector toward greater environmental compatibility. With more than 34,000 employees, the company generated sales of CHF 11.76 billion in 2024.

• Visit cement plants, building strong relationship with the cement market.
• Regular communication with Company’s Director of Cement Additives and Company’s Technical Service.
• Follow closely on-site field trials.
• Jointly work with commercial/technical team to understand the customer requirement, and making adjustment of products to support existing business and capture new market opportunities to grow the business.
• Jointly work with commercial team to gather market intelligence to better understand industry trend and competitors. Working with Product Management to develop new product to grow and improve profitability of the business.
• Develop and regularly update competitors’ product database to support commercial growth.
• Develop, implement, and manage customer complaint process to make sure all complaints are well taken care, timely response to customers, and high degree of customer satisfaction is achieved.
• Provide value added service to customer – seminar, technical presentation, on site troubleshooting.
• Serve as the technical expert to SIKA’s customers by troubleshooting technical issues at the Cement Plant, demonstrating Sika’s product capabilities, recommending solutions and serving as Sika’s representative in technical proposals to the customers. Provide first level of field troubleshooting to customers.
• Promote safety working environment and commit to achieve zero accident target.
• Report to Direct Manager on activity, market, competition, key projects, trials.
  
  

• Diploma / University degree in engineering (preferably chemical engineer)
• 3-5 years hands-on field experience in Cement Industry
• Strong relevant industry and segment knowledge & network
• Strong technical aptitude and willingness to learn and apply knowledge
• A self-starter, excellent time and self-management, require minimum supervision
• Ability to work independently and willing to travel on a frequent basis
• Excellent customer relationship management skill
• Ability to influence and lead multi function to achieve goals
• Good communication and team player
  
  

· 401k with Generous Company Match

· Bonuses

· Medical, Dental, and Vision Benefits

· Paid Parental Leave

· Life Insurance

· Disability Insurance

· Paid time off, paid holidays

· Floating holidays + Paid Volunteer Time

· Wellness/Fitness Reimbursements

· Education Assistance

· Professional Development Opportunities

· Employee Referral Program & More!

Sika fosters a culture of entrepreneurship, empowering each individual to make decisions, learn from experiences, and shape their own career path. The safety and well-being of employees are top priorities at Sika, with a strong commitment to open communication and maintaining a safe workplace. In addition, Sika actively contributes to the community and promotes sustainability by giving back, minimizing environmental impact, and embracing social responsibility.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

We offer competitive salaries, aligned with local market benchmarks and the specific scope and responsibilities of each role. Compensation is determined based skills relevant to the position, education and/or training. We are committed to fair and equitable pay practices in accordance with applicable laws and regulations.

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.