Staff Engineer, R&D Packaging

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 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

$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.

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