Sr Packaging Engineer
About The Position
The Cardiac Surgery Packaging Engineering team supports the development, sustainment, and continuous improvement of sterile packaging systems for medical devices across the product portfolio. The team partners closely with manufacturing sites, quality, regulatory, supply chain, and product development teams to ensure packaging solutions protect product integrity, support patient safety, and meet global regulatory and quality requirements. Responsibilities include sterile barrier design, packaging validation, sustaining engineering activities, compliance initiatives, and manufacturing support. This position is based in Dexter, Michigan. The role follows a flexible work arrangement with an on-site presence expected four days per week and one remote workday per week. The Senior Packaging Engineer supports both sustaining and continuous improvement activities for sterile packaging systems used across the Cardiac Surgery portfolio. This role is responsible for packaging design changes, validation activities, compliance initiatives, manufacturing support, and technical problem solving to ensure packaging systems remain compliant, reliable, and cost effective throughout the product lifecycle.
Requirements
- Bachelor’s degree and 4+ years of packaging engineering, manufacturing engineering, product development engineering, or related engineering experience; or an advanced degree and 2+ years of relevant engineering experience.
Nice To Haves
- Bachelor of Science in Packaging Engineering and 5+ years of packaging engineering experience, or an advanced degree in Packaging Engineering and 3+ years of packaging engineering experience.
- Experience within the medical device industry or another highly regulated manufacturing environment.
- Working knowledge of ISO 11607, ISO 13485, Design Control requirements, and medical device quality system processes.
- Experience with sterilization methods, sterile barrier systems, biomedical materials, and medical packaging design practices.
- Experience applying root cause analysis, CAPA management, Lean principles, Six Sigma methodologies, project management practices, and supply chain collaboration.
- Experience supporting packaging design, packaging validation, or sterile barrier systems within a regulated manufacturing environment.
- Experience developing technical documentation, executing testing activities, and supporting product or process changes through quality management system requirements.
- Knowledge of packaging materials, packaging processes, and engineering problem-solving methodologies.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead sustaining packaging initiatives, including design changes, supplier changes, corrective and preventive actions (CAPAs), cost reduction projects, and supply continuity activities.
- Evaluate released product changes for potential impact to packaging configurations and determine appropriate testing, validation, or redesign requirements.
- Design, develop, and maintain sterile barrier systems, packaging components, assemblies, and specifications in accordance with applicable regulatory and quality standards.
- Plan and execute packaging verification and validation activities, including protocol development, testing, analysis, reporting, and documentation.
- Partner with manufacturing sites and distribution centers to troubleshoot packaging issues, support packaging processes, and provide technical guidance for repackaging operations.
- Support remediation and compliance initiatives, including audits, regulatory submissions, standards assessments, regulation reviews, tender requests, and field complaint investigations.
- Assess packaging materials, processes, and configuration changes to support quality, manufacturability, cost, and sustainability objectives.
- Serve as a packaging subject matter expert on cross-functional teams by managing deliverables, identifying risks, and driving continuous process improvements.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
