Senior Middleware Development Engineer at Intel designing next - gen communication libraries for high - performance computing. Collaborating with teams to optimize software for scientific computing and AI systems.
About the role
- 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
- Leave Programs
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
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