Sr Packaging Engineer

About the role

As a senior professional, this position supports the design, development, validation, commercialization, and sustaining of sterile and non-sterile packaging systems for medical device and capital equipment products for Stroke, Vascular, and Robotics business units. Working under general supervision, this individual will independently execute packaging development activities, support packaging validation efforts, coordinate supplier and laboratory activities, and contribute to the successful commercialization and lifecycle management of products. The Sr Packaging Engineer will collaborate closely with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners while helping drive packaging-related process improvements and operational efficiencies.

Responsibilities

• Design and develop sterile and non-sterile packaging systems for medical devices and capital equipment products
• Participate in design reviews, risk assessments, human factors evaluations, and prototype development
• Coordinate package integrity, seal strength, transportation, distribution, and shelf-life testing
• Collaborate with packaging suppliers, contract manufacturers (CMOs), and third-party laboratories
• Review supplier drawings, tooling designs, specifications, and tolerance stack-ups to ensure packaging performance and manufacturability requirements are met
• Develop and maintain packaging specifications, labeling specifications, Manufacturing Process Instructions (MPI), work instructions, and controlled engineering documentation

Qualifications

• Bachelor's degree in engineering or related discipline
• Minimum of 5 years of related experience in the medical device or related regulated industry; or equivalent combination of education and work experience
• Experience with sterile barrier system (SBS) development, including Tyvek pouches, thermoformed trays, lids, and protective packaging systems
• Experience developing and executing packaging validation protocols and reports in accordance with ISO 11607 and ASTM standards
• Experience reviewing supplier drawings, engineering specifications, tolerances, and packaging design documentation
• Experience supporting packaging equipment qualification and validation, including heat sealers, labeling equipment, and packaging process development
• Working knowledge of SolidWorks or equivalent CAD software, including review of packaging designs, supplier drawings, and dimensional tolerances
• Working knowledge of Minitab, JMP, or similar statistical analysis tools

Benefits

• Stock options
• Bonus
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program

Pay

Salary Range: $132,000 – 158,000/annually. Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. The posted salary range reflects compensation for employees based in the local Bay Area market. For candidates hired outside of this geographic area, compensation may vary and be adjusted based on location, local market conditions, and other factors.