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Sunnyvale, CA 94086

Posted: 03/23/2023 Job Category: Logistics & Supply Chain Job Number: 19252204

Job Description

Primary Skills: Packaging Design, CAD, GMP, Medical Device
Contract Type: W2 only
Duration: 9+ months possible extension
Location: Sunnyvale, CA

NOTE: Role open to Women Back to Work candidates with a career gap
TALK to a recruiter NOW: CONTACT John Jason Paulino at 408-907-6402
Work for a market leader!
  • As part of the Packaging Engineering team, the person in this position will work to design and qualify packaging systems for instruments, accessories, endoscopes and system FRU's across all ISI business units. The work will include designing, validating, and verifying packaging systems that include but not limited to, thermoform packaging such as Form, Fill & Seal trays, rigid trays and/or pouch sterile barrier systems, custom cartons, shippers, over shippers, reusable cases as well as identifying appropriate label stock for all products.
  • Design and develop best in class packaging solutions from early concept through commercialization for sterile and non-sterile medical devices (includes Field Replaceable Units - FRU's). Support packaging needs from concept through end of life.
  • Own of all aspects of design verification of the packaging systems to meet design requirements and release to production and Collaborate with manufacturing and process engineering to implement packaging designs compatible with class 100K clean-room environment.
  • Develop component specifications, inspection plans and packaging protocols/reports to insure that the packaging system performs to requirements.
  • Create and manage change requests within the document control system and Support qualification of sealing/packaging processes within clean room.
  • BS Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field.
  • 5+ years of experience in medical device packaging design development and various packaging processes (high volume preferred).
  • Thorough working knowledge of packaging dynamics, various packaging materials and their compatibility with sterilization processes such as, but not limited to EtO, and Gamma.
  • Knowledge of packaging validation and verification requirements under CFR Part 820, ISO11607 part 1 & 2 and applicable ASTM standards. Strong understanding of GMP.
  • Strong design and project management skills and to manage multiple re-usable and/or single use disposable (SUD) packaging projects across multiple product lines, on time.
  • CAD knowledge and experience (Pro-E or Solidworks) preferred and Must be able to travel occasionally to vendors, subcontractors and ISI Mexico plant
CALL NOW: John Jason Paulino at 408-907-6402
Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. Akraya was recently voted as a 2022 Best Staffing Firm to Temp for by Staffing Industry Analysts and voted by our employees and consultants as a 2022 Glassdoor Best Places to Work

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