Sr Packaging Engineer

Imperative Care•Campbell, CA

5d•$132,000 - $158,000•Onsite

About The Position

Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

Requirements

Bachelor’s degree in engineering, or related discipline and a 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.

Responsibilities

Support 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.
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.
Collaborate closely with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners while helping drive packaging-related process improvements and operational efficiencies.
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.