Stryker
Staff Engineer, R&D Packaging
Stryker, Fremont, California, us, 94537
Work Flexibility: Hybrid
Job Description
Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our focus. 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.
The Staff Engineer, R&D Packaging will be a member of new product development project teams with responsibilities for the design and process development of packaging/labeling components for sterile and non-sterile medical devices
What you will do
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.Create and manage technical protocols, reports, and justifications for packaging design, including the development of procedures, work instructions, and validation protocols.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.What You Need
Minimum Qualifications
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 devicesDemonstrated experience with Medical Device Design Controls, Risk Management, and New Product DevelopmentDemonstrated 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 productsDemonstrated 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
$85,500- $182,100 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.
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 contractor's legal duty to furnish information.
Job Description
Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our focus. 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.
The Staff Engineer, R&D Packaging will be a member of new product development project teams with responsibilities for the design and process development of packaging/labeling components for sterile and non-sterile medical devices
What you will do
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.Create and manage technical protocols, reports, and justifications for packaging design, including the development of procedures, work instructions, and validation protocols.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.What You Need
Minimum Qualifications
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 devicesDemonstrated experience with Medical Device Design Controls, Risk Management, and New Product DevelopmentDemonstrated 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 productsDemonstrated 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
$85,500- $182,100 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.
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 contractor's legal duty to furnish information.