R&D Packaging Engineer II designing and qualifying packaging solutions for medical devices. Lead projects from concept through launch ensuring regulatory compliance and product excellence.
Responsibilities
Lead the design, development, and qualification of packaging systems for sterile and sterile fluid path medical devices, ensuring compliance with ISO 11607-1 & 2 and applicable regulatory standards.
Owner of packaging specifications, responsible for the definition of all packaging system specifications.
Collaborates in the design control process for medium and high complexity projects.
Communicates data analysis including impact and recommended next steps to project/program leadership.
Collaborates on complex projects impacting design inputs/outputs and verification through testing and analysis from start to finish.
Ensures cross-functional strategies are clearly communicated and risks are appropriately managed.
Requirements
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field; advanced degree preferred.
Minimum of 1–4 years of experience in packaging engineering within the medical device or healthcare industry.
Proven track record in designing and developing packaging systems for sterile and non-sterile medical devices, including compliance with ISO 11607-1 & 2 and other relevant standards.
Demonstrated success collaborating with cross-functional projects involving new product development, sustaining engineering, and cost optimization initiatives.
Knowledge in Design for Six Sigma (DFSS), basic statistical analysis, and Design of Experiments (DOE) principles.
Proven ability to define and document packaging requirements for content sterile and sterile fluid path packaging systems for medical devices.
Knowledge designing different packaging system types for medical devices.
Skilled in verification and validation of packaging systems, ensuring compliance with regulatory standards.
Experienced in root cause analysis and failure investigations across diverse packaging designs; adept at leading defect management and Corrective and Preventive Actions (CAPAs).
Experienced developing PFMEA and DFMEA.
Knowledgeable of ISO 11607-1&2, ISO 13485, ISO 16975, and packaging-related ASTM or ISTA standards.
Experience conducting gap assessments, ensuring alignment with FDA, EU MDR or others global packaging compliance requirements.
Proficiency in SolidWorks
Experience developing packaging technical rationales and design verification by analysis
Understanding and application of core engineering principles, including first-principles analysis and calculations, to address packaging design challenges and development activities.
Benefits
Annual Bonus Potential
Discretionary LTI Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
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