Packaging Engineer II

Packaging Engineer II – BD

The R&D Packaging Engineer II plays a critical role in advancing healthcare and supporting the MDS business by leading the development, qualification, and commercialization of innovative packaging solutions for new and existing medical devices. This role combines technical expertise with a passion for innovation, driving projects from concept through launch. The engineer will apply engineering principles to develop and verify packaging systems, conduct root‑cause analyses, and recommend strategic solutions to technical challenges.

With a hands‑on approach and a collaborative mindset, the Packaging Engineer II contributes to product excellence and regulatory compliance.

• 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.
• Own packaging specifications, responsible for the definition of all packaging system specifications.
• Collaborate in the design control process for medium and high complexity projects.
• Communicate data analysis, including impact and recommended next steps, to project and program leadership.
• Collaborate on complex projects impacting design inputs/outputs and verification through testing and analysis from start to finish. Ensure cross‑functional strategies are clearly communicated and risks are appropriately managed.

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field; advanced degree preferred.
• 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 of 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 other global packaging compliance requirements.
• Proficiency in Solid Works.
• 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.

• Annual Bonus
• Potential Discretionary LTI Bonus
• 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 and Long‑term disability coverage, Long‑term care with life insurance
• 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
• 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
• Paid time off (PTO),…