Staff Engineer, R&D Packaging Specialist

4 days ago


Fremont, California, United States Stryker Corporation Full time

Job Title: Staff Engineer, R&D Packaging Specialist

Job Summary: We are seeking a highly skilled Staff Engineer, R&D Packaging Specialist to join our team at Stryker Corporation. The successful candidate will be responsible for designing and developing packaging systems for sterile and non-sterile medical devices.

Key Responsibilities:

  • Lead the design and development of sterile packaging systems for new and existing medical devices, ensuring compliance with regulatory standards and sterilization requirements.
  • Work closely with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure packaging meets product design and functional requirements.
  • Conduct packaging validation and verification, including sealing, transit, and aging studies, in accordance with ISO 11607 and other applicable standards.
  • Develop manufacturing sealing/assembly processes and ensure the packaging design maintains sterility throughout manufacturing, distribution, and shelf life.
  • Ensure compliance with FDA regulations, GMP, and ISO standards related to medical device packaging, and participate in audits and regulatory submissions.
  • Work with suppliers to ensure packaging materials meet design specifications and support design transfer activities from development to manufacturing.
  • Provide ongoing engineering support for packaging improvements, optimizing cost, performance, and sustainability through continuous feedback from post-market surveillance.

Requirements:

  • B.S. degree in Packaging, Industrial, Mechanical engineering or applicable technical field.
  • 4 years of experience with medical device packaging design, development, and verification/validation for sterile/non-sterile medical devices.
  • Demonstrated experience with Medical Device Design Controls, Risk Management, and New Product Development.
  • Demonstrated experience with Industry standards and Test Methods in Medical Device Packaging (11607, ASTM, ISTA, ICH, FDA CFR etc.).

Preferred Qualifications:

  • Demonstrated experience developing sterile packaging design and processes for sterile syringes or injectors for liquids/formulations products.
  • Demonstrated experience in process development, process qualification, and validation for sterile medical device packaging.
  • Experienced in Design of Experiments, Statistical Analysis, interpretation, and communication of data.
  • Strong technical capabilities and project management capability to develop aspects of assigned projects on time, with smart risks and within budget.

What We Offer:

  • $85,500 - $182,100 salary plus bonus eligible + benefits.
  • 20% travel percentage.

About Stryker Corporation: Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.



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