Senior Staff Engineer, R&D Packaging
Senior Staff Engineer, R&D Packaging
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Job Description
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 Strykers Neurovascular portfolio visit: Stryker Neurovascular
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.
$130700 - $215300 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 20%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 contractors legal duty to furnish information.Required Experience:
Staff IC
Employment Type
Full-Time
