Staff Engineer, Packaging - Wayne, NJ

Getinge•Wayne, NJ

8d•$120,000 - $145,000•Onsite

About The Position

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.

Requirements

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related technical discipline.
Minimum 8+ 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.
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.
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.
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.

Nice To Haves

Master's degree in Engineering, Packaging Engineering, or related discipline.
Certified Packaging Professional (CPP) or equivalent professional certification.
Experience supporting Class II and Class III medical devices.
Experience working in global manufacturing environments.
Experience leading or mentoring engineering teams.
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

Responsibilities

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.
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.
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.
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.
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.