Engineering Village Jobs in None, NJ

About Diversified:

Diversified is a global leader in audio visual and media innovation, recognized for designing and building the world's most experiential environments. Our award-winning team specializes in delivering solutions for the most complex, large-scale and immersive installations. Serving a global clientele that includes major media organizations and retailers, sports and live performance venues, corporate enterprises, and government agencies, Diversified partners with clients to create spaces that bring people together and keep them coming back.

What to Expect:

At Diversified, we're on a mission to create a world without boundaries, where technology enables all people to connect and experience the moments that matter, wherever they choose to be. With clients spanning the globe and an exciting pipeline of projects across industries, Diversified offers more than just a job. We offer a career path with the flexibility to grow personally and professionally, wherever your ambitions take you.

As a Diversified associate, you'll dive headfirst into big, complex, and rewarding projects that push the boundaries of what's possible. Plus, you'll enjoy a flexible work environment, competitive compensation and benefits, and a culture that celebrates diversity and inclusion.

IF YOU CAN DREAM IT, YOU CAN DO IT AT DIVERSIFIED.

The Engineering Leader is responsible for leading the Design Engineering organization across the company and ensuring consistent, high-quality, and profitable project delivery. Reporting to the Vice President of Engineering Operations, this role oversees Engineering Managers and Design Engineering teams, driving accountability, operational efficiency, and technical excellence throughout the project lifecycle.

A core focus of this position is ensuring Design and Project Engineers are positioned to perform their highest-value work-developing client relationships, shaping execution strategies, and ensuring system accuracy and expected functionality. This role partners closely with Engineering Documentation leadership to ensure documentation and support workflows are effectively leveraged, allowing Design Engineering resources to remain focused on technical leadership and client-facing responsibilities.

Responsibilities include, but are not limited to:

• 
  
  
• Own the performance, development, and accountability of Engineering Managers leading Design Engineering teams, setting clear expectations and holding leaders responsible for team results, delivery quality, and professional growth.
  
  
• Establish and sustain a culture of ownership and accountability across the engineering organization by defining measurable standards for project delivery, documentation quality, and client satisfaction, and addressing performance gaps directly.
  
  
• Drive engineering efficiency and profitability by identifying misaligned workflows, reducing non-value-added engineering effort, and ensuring appropriate use of engineering support and documentation resources.
  
  
• Partner with Support Engineering leadership to ensure effective utilization of engineering support teams, removing barriers that prevent smooth handoff and enabling Engineers to focus on high-value technical work.
  
  
• Ensure Engineers are consistently focused on client relationship development, execution planning, technical accuracy, and system functionality throughout the project lifecycle.
  
  
• Maintain visibility into presales pipeline and active project lifecycle status, comparing as-sold versus as-delivered labor, identifying value-engineering opportunities, and supporting financial performance improvement.
  
  
• Collaborate with Field and Fabrication Services and Project Management leadership to align engineering capacity with project demand, participating in resource planning and ensuring engineering support meets business needs.
  
  
• Establish, enforce, and audit engineering standards and delivery processes that support consistent, high-quality outcomes, reducing variability and improving first-time quality across projects.
  
  
• Serve as the senior escalation point for engineering-related issues impacting project delivery or client satisfaction, intervening when projects are off track and guiding recovery plans with responsible managers.
  
  
• Provide leadership input on hiring, succession planning, and organizational design for Engineering Manager roles, ensuring alignment with technical requirements and cultural expectations.
  
  
• Track, analyze, and act on key engineering performance metrics, including utilization, margin contribution, rework rates, schedule adherence, and client satisfaction, using data to drive continuous improvement.
  
  

Required Skills and Experience

• 
  
  
• Bachelor Degree Required, preferably in Engineering, Construction Management or related field.
  
  
• 10+ years of experience in systems integration, audiovisual engineering, or a related technical field with progressive leadership responsibility.
  
  
• 3+ years of experience managing managers or leading large, multi-project technical teams.
  
  
• AVIXA CTS, CTS-I, or CTS-D certification.
  Demonstrated success improving team performance and delivering measurable business results.
  
  
• Experience developing, implementing, and enforcing engineering standards and processes at scale.
  
  
• Strong understanding of the full project lifecycle from design through commissioning.
  
  
• Experience partnering cross-functionally with Sales, Project Management, and Field & Fabrication Services.
  
  
• Ability to read and interpret architectural drawings, system schematics, and technical specifications.
  
  
• Financial acumen, including labor forecasting, project budgets, and margin impact analysis.
  
  
• Strong problem-solving skills with a bias toward action and resolution.
  
  
• Effective written and verbal communication skills suitable for executive-level engagement.
  
  

What We Offer:

Along with competitive compensation, you will be eligible for the following benefits:

• 
  
  
• Multiple medical plan options to suit your family's needs
  
  
• Dental (including orthodontic coverage) and vision plans
  
  
• Company paid Basic Life, AD&D, Short-Term and Long-Term Disability Insurance, and Employee Assistance Plan (EAP)
  
  
• Healthcare and Dependent Care Flexible Spending Accounts (FSA)
  
  
• 401k with Employer Match
  
  
• Paid Time Off and Paid Holidays
  
  
• Voluntary Benefits: Critical Illness, Hospital Indemnity, Accident Insurance, Pet Insurance, Homeowners and Auto Insurance, Supplemental Term and Dependent Life and AD&D, and Legal Services
  
  
• Commuter Benefits
  
  
• And much more
  
  

To learn more about becoming part of the Diversified team, visit us at our career siteor email us at .

Diversified is an equal opportunity employer committed to fostering an inclusive and diverse workplace. All aspects of employment will be based on job requirements, individual qualifications, merit, performance, and business need. We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic under applicable law. We believe in fair and equitable hiring practices and strive to create an environment where all individuals feel valued and empowered.

If you require a reasonable accommodation to participate in the application or interview process due to a disability, please contact so we can assist you.

Our compensation ranges reflect the cost of labor across several US geographic markets. The pay details below range from our lowest geographic market up to our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills and experience depending on the position offered, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits.

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.

Position: Engineering Manager

Location: Camden County, NJ

Position Summary

The Engineering Manager is responsible for leading a team of engineers and technical personnel who support the ongoing performance, reliability, and continuous improvement of existing manufacturing operations. This role ensures that production systems, processes, and products operate efficiently while driving initiatives related to cost reduction, product performance improvements, and operational excellence.

• The manager will serve as the primary engineering liaison to production, collaborating closely with operations, quality, supply chain, and product development teams to resolve technical challenges and implement process improvements. This is a hands-on leadership role suited for an individual who thrives in a fast-paced manufacturing environment and is passionate about improving processes, quality, and product performance.

Key Responsibilities

Team Leadership

• Lead, mentor, and develop a team of engineers and technical staff responsible for supporting existing manufacturing operations.
• Foster collaboration between engineering, operations, and quality teams to drive operational excellence initiatives.
• Establish clear priorities and ensure engineering resources are effectively aligned with production needs.

Manufacturing & Production Support

• Serve as the primary engineering point-of-contact for manufacturing operations.
• Provide technical guidance and troubleshooting support to maximize production uptime and efficiency.
• Maintain accurate engineering definitions including bills of materials (BOMs), standard operating procedures (SOPs), drawings, and process specifications.
• Lead engineering projects focused on product performance improvements, cost reduction, and reliability enhancements.

Quality & Root Cause Analysis

• Partner with the Quality team to investigate production or field failures.
• Lead root cause analysis and implement corrective and preventive actions.
• Support quality initiatives aimed at improving product reliability and manufacturing consistency.

Engineering Change Management

• Manage and oversee the Engineering Change Order (ECO) process from initiation through implementation.
• Ensure engineering and quality documentation remains accurate and up to date.
• Coordinate cross-functional communication during product or process changes.

Process Improvement & Lean Initiatives

• Drive continuous improvement initiatives using Lean manufacturing and statistical problem-solving methodologies.
• Identify opportunities to improve assembly processes, reduce waste, and optimize workflow.
• Support preventative maintenance initiatives and long-term equipment reliability.

Cross-Functional Collaboration

• Work closely with R&D, operations, supply chain, and customer support teams to support product lifecycle management.
• Assist supply chain teams with evaluation of alternate components or suppliers to mitigate supply risks.
• Ensure alignment between engineering initiatives and broader operational goals.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, or a related technical discipline.
• 10 years of engineering experience within a manufacturing environment.
• Minimum of 5 years of leadership or management experience.
• Experience supporting manufacturing operations in a sustaining or production engineering capacity.
• Strong knowledge of Lean manufacturing principles and structured problem-solving methods.
• Experience with 3D CAD tools such as SolidWorks and the ability to interpret technical drawings.
• Familiarity with Engineering Change Orders (ECO) or Engineering Change Notices (ECN).
• Excellent leadership, communication, and organizational skills.
• Strong mechanical aptitude and the ability to solve complex technical issues in a fast-paced environment.

Program Dates: May 27th through August 7th

About Wakefern

Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite®, Price Rite®, The Fresh Grocer®, Dearborn Markets®, Fairway Markets®, Gourmet Garage®, and Morton Williams® banners.

Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern’s co-operative members benefit from the company’s extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices.

About You

As more real estate opportunities present themselves due to the ever-changing market in the Mid-Atlantic area, Wakefern, in conjunction with our Members, is investing in many new stores and remodel projects. Additionally, as Wakefern grows to meet these needs, our facilities also need to be expanded and re-configured to accommodate this growth.

This internship position is a great opportunity for a student majoring in Engineering, Industrial Engineering, Construction Management, Architecture, or other related fields to gain hands-on experience working with Wakefern’s Engineering Division. In this position, the intern will assist the Engineering team in project management in our Retail Engineering Design Department.

Responsibilities:

Facilities Engineering / Design and Construction

• Assist Engineering in preparation of plans using AutoCAD
• Assist Engineering Personnel in surveys of existing sites and stores to verify existing conditions
• Assist in drafting of remodels or new sites, including parking lots and stores
• Coordinate scanning of existing paper drawings into electronic files
• Visit new sites to determine best layout for building, parking and truck docks as well as truck paths through the site.

Requirements:

• Strong MS Office skills (Excel, Word and PowerPoint). Some Experience with AutoCAD or other CAD file Software required
• Valid driver's license and flexibility with regard to travel required
• Strong interpersonal, analytical and customer service skills with the ability to multitask and manage time effectively
• Excellent communication skills (written, oral and presentation)
• Ability to exhibit proper business etiquette when dealing with all levels of the organization
• Detail oriented, analytical and the ability to work in a team environment
• 5 days on site - no remote work
• Various projects as assigned

What we are looking for

• Must be at least 18 years old
• Must have completed 24 college credits with a 3.0 cumulative GPA or better
• Will be enrolled in an undergraduate or graduate school for fall
• Successful completion of a substance abuse test is required
• Successful completion of a background check is required
• Reliable transportation is required
• Strong interpersonal, analytical, and customer service skills with the ability to multitask and manage time effectively
• Excellent communication skills (written, oral, and presentation)
• Strong MS Office skills (Excel, Word, and PowerPoint required)
• Ability to exhibit proper business etiquette when dealing with all levels of the organization
• Previous work experience in a retail environment is beneficial
• Must have flexibility with regard to schedule which can include coverage for a 7-day work week, weekends, holidays, vacations and peak volume weeks (interns will work 40 hours per week)

Company Perks

• Vibrant Food Centric Culture
• Corporate Training and Development University
• Collaborative Team Environment
• Educational Workshops
• Networking Opportunities
• Volunteer Opportunities

Compensation and Benefits:

First year Facilities Engineering Interns will be paid at $17.00 per hour. Master Students and Returning Wakefern Supply Chain/Logistic Interns will be paid at $19.00 per hour. Interns are not eligible for company benefits including medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off and holidays.

Join a mission-driven environmental and engineering consulting firm that has been delivering innovative water resources and ecological restoration solutions. This Geotechnical Engineer / Technical Project Manager (PE Required) opportunity is based in Trenton or Sicklerville, NJ and offers the chance to work on meaningful projects such as stormwater management systems, dam removals, wetland restoration, coastal protection, and floodplain reconnections. If you’re passionate about sustainable infrastructure and want to collaborate with a team that values environmental stewardship, creativity, and a positive work culture, this is an exciting place to grow your career.

Qualifications and responsibilities for this Geotechnical Engineer / Technical Project Manager position include:

• Bachelor’s degree in Civil Engineering – Plan and execute subsurface investigations for land and water-based projects
• Professional Engineer (PE) license required – Perform geotechnical analyses including slope stability, seepage, bearing capacity, settlement, and liquefaction
• 6+ years of geotechnical engineering experience – Lead and manage geotechnical aspects of ecological restoration and water resources projects
• Experience with foundation and earth structure design – Analyze axial and lateral capacities of deep foundations and sheet pile systems
• Proficiency in AutoCAD and Civil 3D – Prepare geotechnical reports, drawings, and technical plans
• Strong written and verbal communication skills – Prepare proposals, technical reports, and present findings to clients and stakeholders
• Project management and time management skills – Oversee multiple projects including scheduling, coordination, and client interaction
• Leadership and mentoring ability – Train junior staff and provide geotechnical guidance across multiple practice areas

Salary: $95,000 - $125,000 per year, commensurate with experience.

Benefits: This full-time, permanent, direct-hire position offers great benefits including medical, dental, and vision insurance; a 401(k) plan with a 5% company match after three months and immediate vesting; paid vacation and personal time off; paid parental leave; and a hybrid work schedule with flexible core hours.

DAVRON is the leading Headhunter and Executive Search firm for Engineering, Architecture, Construction and Manufacturing professionals nationwide. Our recruiters have direct communication with hiring managers allowing us to get you in front of company decision makers. You also receive one-on-one interview preparation and insider coaching from staffing experts to help you every step of the way. We want to see you thrive in challenging work environments that bring you excitement and prosperity in your career!

Apply Now!

Are you ready to take the next step in your career and thrive in a challenging work environment? If so, apply today and let's see where this opportunity can take you!

GEOTECHNICAL ENGINEER | TECHNICAL PROJECT MANAGER | PROFESSIONAL ENGINEER (PE) | AUTOCAD | CIVIL 3D | GEOTECHNICAL ANALYSIS | DAM & LEVEE DESIGN | STORMWATER MANAGEMENT | WETLAND RESTORATION | FOUNDATION DESIGN | HYDROLOGIC & HYDRAULIC ANALYSIS | CONSTRUCTION OVERSIGHT

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.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates crossfunctionally to support timely resolution of product issues and support corrective and preventive actions.

Job Responsibilities and Essential Duties

• 
  
• Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
  
• Initiate, own and support Corrective and/or Preventive Actions
  
• Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
  
• This is not an inclusive list of job responsibilities
  

Required Knowledge, Skills and Abilities

• 
  
• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
  
• Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
  
• General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
  
• Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
  
• Experienced with handling Biohazard materials.
  

• 
  
• Experience with laboratory work in the medical devices industry.
  
• Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
  
• Excellent written and verbal communication skills.
  
• Strong problem-solving skills and a passion for investigation and root cause analysis
  
• Strong interpersonal skills.
  
• Good organizational skills. Must be able to adhere to timelines.
  
• Basic understanding of statistical analysis.
  
• Basic understanding of quality systems
  

The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 8% Annual Bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.

Job Responsibilities and Essential Duties

• 
  
• Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
  
• Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
  
• Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
  
• Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
  
• Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
  
• Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
  
• Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
  
• Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
  
• Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
  
• Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
  
• Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
  
• Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
  
• Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
  
• Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
  
• Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
  
• Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
  

Minimum Requirements

• 
  
• Bachelor's degree in engineering, Science, or other related field is required.
  
• Six Sigma Green Belt or other applicable certifications are a plus.
  
• Minimum 1 year experience in Quality or Engineering.
  
• Experience in a medical device or pharmaceutical industry.
  
• Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
  
• Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
  
• Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
  
• Project management and leadership experience is desirable.
  
• Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
  

Required Knowledge, Skills and Abilities

• 
  
• Strong analytical and problem-solving skills.
  
• Excellent communication and interpersonal skills.
  
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
  
• Ability to work effectively in a cross-functional team environment.
  
• Ability to review and understand technical standards and their requirements for products.
  
• Lead improvement initiatives, either independently or as part of cross-functional teams
  

The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.