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Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our mission. From the moment a product is manufactured to its use in the angio suite, the packaging and labeling make a difference in so many ways.

As a Senior Staff Engineer, R&D Packaging, you will be a key member on new product development project teams, driving the design and development of packaging components, artwork, design verification, shelf life testing, label design, and support regulatory submissions.

To learn more about Stryker’s Neurovascular portfolio visit: Stryker Neurovascular (https://www.stryker.com/us/en/portfolios/neurotechnology-spine/neurovascular.html)

This is a hybrid position. You will need to live within commuting distance to our Fremont, California office. You will need to be in the office 3 days a week and can work from home on other days.

What you will do

+ Design and develop best-in-class packaging and labeling solutions for sterile and non-sterile medical devices and combination products, from concept through commercialization.

+ Develop packaging and labeling components that enhance the customer experience, partnering with drafters to create 3D models and artwork.

+ Lead or co-manage packaging and labeling projects to drive changes across the product portfolio.

+ Drive continuous improvement by assessing current procedures and incorporating Voice of Customer insights.

+ Collaborate cross-functionally with quality, manufacturing, regulatory, clinical, marketing, R&D device designers, supply chain, vendors, and kitting centers to ensure project success.

+ Build quality into all aspects of product development, ensuring compliance with regulatory and sterilization standards, and leading improvements in complex areas.

+ Support audits, non-conformances, and CAPAs as needed.

+ Mentor and support technical staff to strengthen team capability and deliver high-quality results.

What you need

Required Qualifications:

+ B.S. degree in Packaging, Industrial, Mechanical Engineering, or applicable technical field.

+ 6+ years of related work experience in engineering; packaging highly preferred.

+ Experience in medical device, biotech, combination products, or pharmaceutical packaging and labeling design and development.

+ Proven experience leading design and development of sterile and non-sterile packaging systems, ensuring compliance with regulatory and sterilization requirements.

+ Knowledge of Design Controls and Packaging Design standards (11607, ASTM, or ISTA).

+ Experience with packaging validation and verification, including sealing, distribution, and shelf-life studies per industry standards.

Preferred Qualifications

+ Experience conducting voice of customer research and usability studies with healthcare staff.

+ Experience in process development for packaging/labeling assembly, including design of experiments, equipment specifications, fixture designs, and IQ/OQ/PQs.

+ Demonstrated experience developing sterile packaging design and processes for syringes or injectors for liquids/formulations.

+ Knowledge in labeling systems and IFU development.

+ Experience with statistical analysis tools such as Minitab.

**$130,700 - $215,300** salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.