Role OverviewThis role is responsible for on-going sustaining and improvement efforts for purchased parts with a focus on packaging and labeling. The Senior Supplier Engineer supports supplier regulatory, environmental, and compliance execution for the Endoluminal business unit, ensuring suppliers and parts meet global requirements for qualification, release, and sustained production.
What You Will Do
Provide supplier DFM feedback on specifications with a focus on packaging materials and designs. Own purchased part qualification activities for packaging and labeling commodities. Work closely with product design, manufacturing, and project teams to resolve supplier quality issues and implement improvements to performance, quality, capacity, and cost.
Why It Might Be a Fit
The ideal candidate will have demonstrated ability to partner effectively with Quality, Regulatory, Environmental, and Compliance organizations. Strong working knowledge of global regulatory and environmental compliance requirements is required.
Requirements
- BS degree in Engineering or equivalent
- Minimum 8 years related experience in Supplier Quality Engineering and/or Supplier Development or related field
- Demonstrated ability to partner effectively with Quality, Regulatory, Environmental, and Compliance organizations
- Strong working knowledge of global regulatory and environmental compliance requirements impacting supplied parts and assemblies
- Experience with packaging materials and regulations such as thermoforming trays, pouches, cartons, adhesives UDI, country-specific labeling, and UL requirements as needed
- Demonstrated experience in SCARs and CAPAs using excellent analytical, problem-solving, and engineering judgment skills
- Strong written and verbal communication skills, including presentations to senior and executive leadership
- Working knowledge of 21 CFR Part 820 and ISO 13485, including supplier auditing experience
- Proficiency with common business tools and ERP systems (SAP preferred)
- Ability to read and interpret mechanical drawings and technical specifications
Benefits
- market-competitive compensation packages
- incentives
- benefits
- equity
]]>