Work Flexibility: Hybrid or Onsite
Senior Engineer, R&D Packaging
Fremont, CA
As a Senior Engineer, R&D Packaging, you will support the development, verification, and maintenance of packaging and labeling solutions for medical devices, partnering with cross-functional teams across the product lifecycle. This role offers the opportunity to work on both sustaining and improvement initiatives while ensuring compliance, product quality, and customer-focused packaging performance.
What You Will Do
- Develop packaging and labeling components for sterile and non-sterile medical devices, including artwork, instructions for use, and packaging specifications.
- Lead or support packaging and labeling projects from concept through commercialization, delivering project milestones on schedule.
- Author and execute design verification, transit testing, and shelf-life validation protocols and reports to support product requirements.
- Collaborate with quality, manufacturing, regulatory, clinical, marketing, supply chain, and R&D teams to drive project execution and maintain compliance.
- Evaluate Voice of Customer feedback, product performance data, and current processes to identify and implement continuous improvement opportunities.
- Support audits, non-conformances, corrective and preventive actions (CAPAs), and investigations related to packaging and labeling systems.
- Apply packaging design standards and regulatory requirements to ensure compliant packaging solutions and documentation.
- Mentor technical team members and provide technical guidance on packaging development, testing, and problem resolution.
What You Will Need
Required Qualifications
- Bachelor’s degree in Packaging Engineering, Industrial Engineering, Mechanical Engineering, or another related technical field.
- Minimum 2 years of experience in a highly regulated industry.
Preferred Qualifications
- Experience developing, testing, or supporting packaging and labeling solutions.
- Experience authoring technical documentation, including protocols, reports, specifications, or validation documentation.
- Experience in medical device, biotechnology, or pharmaceutical packaging development.
- Knowledge of packaging design and testing standards, including ISO 11607, ASTM, and ISTA.
- Experience with database-driven labeling systems, label development, or instructions for use (IFU) development.
- Experience with statistical analysis and interpretation of test results.
- $101,000 - $168,400 USD Annual
Travel Percentage: None
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. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.