Sr Manufacturing Packaging Engineer

Stryker is seeking a Sr Manufacturing Packaging Engineer to join the Mahwah, New Jersey joint replacement manufacturing facility.

Who we want-

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do-

As a Sr Manufacturing Packaging Engineer within the manufacturing operations team, you will provide packaging manufacturing engineering support and lead multiple complex projects for the packaging cell.

In this role you will work closely with quality assurance, suppliers, advanced operations, and product development on initiatives that drive toward best practices and support business objectives.

Additional responsibilities:

• Develop and manage project timelines within a cross-functional team
• Define and implement specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results
• Work closely with Operations, Engineering Services and Quality to resolve in-house and supplier quality problems using established problem-solving methodologies
• Actively participate and lead teams to support new product and process design and development activities
• Lead and participate in the development and improvement of the manufacturing process for existing and new products
• Review and approve inspection plans, routers and product drawings
• Facilitate quality remediation and gap closure through partnership with cell Quality Engineer
• Participate in development, review and approval process and equipment validation/qualifications
• Review and approve nonconforming material and system documentation
• Initiate and support non-conformance reports and corrective and preventative action initiatives
• Under minimal supervision, lead, execute and close complex projects

What you need-

• Bachelor’s degree in engineering required
• 2+ years of related work experience required
• Experience working in a highly regulated industry required
• Familiarity with sterilization operations (Gamma, ETO and Gas Plasma (peroxide)) for sterile implants and/or instruments required
• Demonstrated understanding of cleanroom processing, certification and environmental monitoring for ISO class 8 cleanrooms required
• Ability to define root cause of different manufacturing equipment specifically packaging equipment required
• Understanding of aqueous and solvent cleaning processing for sterile implants and instruments (both automated and manual processing) -preferred
• Understanding of sterile barrier packaging and package testing (in process/AQL, stability testing and age testing) -preferred
• Experience creating detailed drawings for fixture/tooling designs and/or the ability to work with designers and drafters to create fixture/tooling designs -preferred
• Working knowledge of quality tools such as failure modes effect analysis (FMEA), GD&T, root cause analysis, mistake proofing and Poke-Yoke -preferred
• Demonstrated proficiency in LEAN and problem-solving tools with a high focus on process improvement such as DMAIC and Value Stream Mapping -preferred