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Skills: Packaging Engineering, Sterile Barrier Systems, ISO 11607, Medical Device Validation, Risk Management
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$120k–$145k/yr
Full-time
bachelor degree, postgraduate degree, professional certificate
Health Insurance, Dental Insurance, Vision Insurance, 401k Plan With Company Match, Paid Time Off, Wellness Initiative & Health Assistance Resources
Posted 25d ago
~40 hrs/week
Responsibilities
Serve as the technical subject matter expert for packaging systems, labeling, and sterile barrier solutions for Cardiac Surgery and Vascular Intervention portfolios. Lead the development, validation, and lifecycle management of complex packaging while ensuring global regulatory compliance.
Requirements
Requires a Bachelor's degree in Engineering or Materials Science and at least 8 years of packaging experience in a regulated healthcare industry. Expert knowledge of ISO 11607 and medical device validation methodologies is essential.
Full job description
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 serves as a technical leader and subject matter expert for packaging systems, labeling, and sterile barrier solutions supporting Cardiac Surgery and Vascular Intervention product portfolios. This role drives the development, validation, commercialization, lifecycle management, and continuous improvement of complex packaging systems while ensuring compliance with global regulatory requirements.
The Staff Packaging Engineer provides strategic technical leadership across multiple programs, mentors engineers, influences packaging standards and best practices, partners with cross-functional stakeholders, and leads initiatives that improve product quality, patient safety, manufacturing efficiency, supply continuity, and total cost of ownership
Job Responsibilities and Essential Duties
Technical Leadership
Serve as the packaging engineering subject matter expert (SME) for sterile and non-sterile medical device packaging systems.
Lead packaging strategy, design, development, validation, and commercialization activities for new product development and sustaining engineering projects.
Establish technical direction for packaging technologies, materials, validation methodologies, and packaging standards.
Drive innovation and continuous improvement initiatives focused on quality, reliability, sustainability, manufacturability, and cost optimization.
Mentor and provide technical guidance to packaging engineers and cross-functional project teams.
Packaging Development
Lead the design and development of sterile barrier systems and protective packaging solutions in compliance with ISO 11607 and applicable global regulations.
Evaluate and select packaging materials based on product requirements, sterilization compatibility, transportation risks, shelf-life requirements, and environmental considerations.
Guide packaging architecture decisions across product platforms and manufacturing sites.
Lead packaging component specifications, drawings, and technical documentation development.
Support platform standardization and harmonization initiatives across the portfolio.
Validation and Compliance
Develop and approve validation strategies and protocols including: IQ, OQ, PQ, Process validation, Packaging validation, Package integrity testing, Transportation simulation testing, Accelerated and real-time aging studies, and Labeling system validation
Lead risk assessments utilizing Design Failure Mode and Effects Analysis (DFMEA), Process FMEA, and hazard analysis methodologies.
Ensure compliance with ISO 11607, ISO 13485, FDA 21 CFR Part 820, EU MDR, UDI requirements and Global medical device regulations
Manufacturing and Operations Support
Partner with Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Operations teams to implement robust packaging solutions.
Lead resolution of packaging-related manufacturing issues and non-conformances.
Support investigations, CAPAs, complaint trending, and quality system activities.
Drive process capability improvements through statistical analysis and data-driven decision-making.
Lead supplier qualification activities and packaging component change management.
Strategic and Business Impact
Lead cross-functional projects with significant business, technical, and regulatory complexity.
Identify and execute cost reduction opportunities through packaging redesign, material optimization, and supplier management.
Support business continuity initiatives related to packaging materials and suppliers.
Influence organizational packaging standards, engineering practices, and technology roadmaps.
Present technical recommendations and project updates to senior leadership.
Minimum Requirements
Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related technical discipline. Master's degree in Engineering, Packaging Engineering, or related discipline (preferred).
Minimum8+ of progressively responsible packaging engineering experience preferably within the medical device, pharmaceutical, or regulated healthcare industry.
Demonstrated experience leading complex packaging development and validation programs from concept through commercialization.
Proven track record influencing technical decisions across cross-functional teams.
Certified Packaging Professional (CPP) or equivalent professional certification (preferred).
Experience supporting Class II and Class III medical devices (preferred).
Experience working in global manufacturing environments (preferred).
Experience leading or mentoring engineering teams (preferred).
Technical Expertise
Expert knowledge of ISO 11607 Parts 1 & 2, ISO 13485, ASTM packaging standards, Medical device packaging validation methodologies, Sterile barrier systems, Cleanroom packaging processes and Labeling regulations and UDI requirements
Strong understanding of Design Controls, Risk Management (ISO 14971), CAPA systems, Change Control, Complaint Investigations and Validation requirements
Analytical Skills
Advanced statistical analysis capability using Minitab or equivalent tools.
Process capability analysis and design of experiments (DOE).
Root cause investigation and structured problem-solving methodologies.
Ability to interpret complex technical data and make risk-based decisions.
Leadership Skills
Ability to influence without direct authority.
Strong project leadership and stakeholder management skills.
Effective mentoring and coaching of engineering personnel.
Strong presentation and communication skills with senior management and external stakeholders.
Preferred Software Proficiency in Minitab, SAP and/or PLM systems, Labeling systems, SolidWorks, AutoCAD, TOPS, CAPE, Microsoft Office Suite and Statistical and data analysis software
Salary range: $120k -$145k plus bonus targeted at 10% (depending on overall company performance)
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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.
Related keywords
ISO 11607ISO 13485FDA 21 CFR Part 820EU MDRUDIISO 14971Sterile Barrier SystemsMinitabSAPPLMSolidWorksAutoCADTOPSCAPEDFMEAProcess FMEA
We exist to make life-saving technology accessible to more people.
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Headquarters
Gothenburg
LinkedIn followers
344,958
Total funding
$539M
At Getinge, we are committed to meet today's health care challenges together with health care providers and be part of improving patients’ lives around the globe.
Our offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science.
Our journey started in the village of Getinge on the Swedish west coast back in 1904. Today, our operations cover more than 40 countries and we have over 10 000 employees. Every single one of us with the firm belief that saving lives is the best job in the world.
Please be aware that LinkedIn is a third-party operated social media site unaffiliated with Getinge. Getinge does not control and is not responsible for the privacy or security policies or practices on this site or any third-party websites that we may link to through this site. We recommend that you carefully review the privacy and security practices of this site and any linked third-party websites. We are not responsible for the accuracy of any information, opinions, claims, or statements posted by our followers or other users of this site. Getinge reserves all rights relating to our account on this site, including, but not limited to, removing postings.
While Getinge's product-related advertisement and information is intended to be disseminated only in jurisdictions where the license to market such products has been granted, Getinge has no control over how our posted content is further disseminated through LinkedIn. Therefore, as posts are shared or liked by our followers or other LinkedIn users, we have no control over the geographic reach of such posts, comments, and communications. Please, note the foregoing when reading product-related social media posts and corroborate with local representatives for product licensing.
Offices: Lindholmspiren 7, P.O. Box 8861, Gothenburg, SE-417 56, SE · 40 Continental Blvd, Merrimack, NH 03054, US · Avenida Manuel Bandeira, 291, Bloco B - 2o andar - conjuntos 33 e 34, Sao Paulo, SP 05317-020, BR · 45 Barbour Pond Dr, Wayne, NJ 07470, US · 1 Geoffrey Way, Wayne, New Jersey 07470, US
Based on 3807 listings with disclosed salaries, most healthcare jobs in New Jersey pay between $70k–$210k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in New Jersey right now?
There are currently 16,373 open healthcare positions in New Jersey listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in New Jersey?
Companies currently hiring include Hackensack Meridian Health, CVS Health, Atlantic Health, Cooper University Health Care, BAYADA Home Health Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in New Jersey?
Yes — 2074 of the 16373 open healthcare positions offer remote or hybrid work (573 remote, 1501 hybrid).
How do I apply for Healthcare jobs in New Jersey?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.