Engineering Jobs in Ridgewood, NJ

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.

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.

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

About us:

We’re Five Star Millwork — a fast growing millwork & trim work company based in Pearl River, NY, with a reputation for exceptional craftsmanship and attention to detail. From high-end millwork to custom kitchen installations, we take pride in delivering work that’s built to last. Our sister companies, Master Trimmer and Five Star Kitchen Design Center, work hand-in-hand to bring beautiful residential and commercial spaces to life.

The Role:

We're looking for an Estimator with specific finish carpentry experience who is ready to work in a fast-paced culture. The Finish Carpentry Estimator will be responsible for all aspects of preparing hard bid construction cost estimates. Responsibilities include plan take-offs, estimating, proposal preparation, negotiations, pre-construction coordination, client relations, and bid tracking. If you are a self-motivated Estimator with sound judgement, strong communication/interpersonal skills, and confidently develops accurate construction bids then we would love to hear from you! Ideally, you will possess knowledge in construction means and methods, costs, and engineering principles to hit the ground running.

The Responsibilities:

• Read and interpret project documents, understand project logistics, understand project schedule, and develop scopes of work.
• Perform detailed and accurate quantity takeoffs and obtain material pricing.
• Work with Five Star Millwork LLC management and field operation teams to estimate labor production rates, identify project efficiencies, and identify alternate approaches.
• Attend client pre-bid meetings, visit project sites, take notes, and assess site-specific conditions.
• Submit and follow up pre-bid requests for information.
• Prepare bids itemized by specification section and detailed into labor, material, equipment, subcontractor, and overhead costs.
• Present bids to management, succinctly explaining estimate details and project specifics.
• Prepare accurate and competitive hard bid construction cost estimates and submit formal proposals in a timely manner.
• Maintain detailed and orderly project files, adhering to Five Star Millwork quality standards.
• Follow up on bid results.
• Build relationships with clients, contractors, and vendors.
• Perform pier reviews of estimates and proposals. Troubleshoot and resolve estimate issues.
• Maintain past performance databases and spreadsheets.
• Research data on industry standard labor production rates and material costs.
• Maintain the bid board, bid tracking logs, customer history, and material management.
• Identify and recommend improvements to the bidding process.
• Maintain professional & technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

What you bring:

• Bachelor’s degree in Engineering, Architecture, Construction Management, or 10 years’ experience carpentry construction.
• Strong interpersonal and communication skills with the ability to develop and maintain a business relationship with clients and vendors.
• Experience estimating commercial and residential carpentry projects that include finish carpentry, and doors.
• Knowledge of applicable codes and standards.
• Experience with estimating takeoff software.
• Experience estimating construction projects $10,000 to $5,000,000.
• Proficient in Microsoft Windows, Word, Excel, PlanSwift and Quickbooks.
• Superior written and oral communication skills.

Benefits:

• Casual yet professional environment
• Competitive pay
• Paid vacation and holidays
• A yearly review
• Co-workers you enjoy working with

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.