Job DescriptionPrimary Function of Position This role is responsible for on-going sustaining and improvement efforts for purchased parts with a focus on packaging and labeling. In addition, this role 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.
Essential Job Duties Purchased Part Qualification and Improvement - Provide supplier DFM feedback on specifications with a focus on packaging materials and designs in collaboration with packaging design team (e.g. pouches, cartons, thermoformed trays, adhesives).
- Own purchased part qualification activities for packaging and labeling commodities which may include pFMEAs, control plans, FAIRS, Cpk, Supplier Validation, and Test method validation.
- Work closely with product design, manufacturing, and project teams to resolve supplier quality issues and implement improvements to performance, quality, capacity, and cost. Mange project plans and timelines
- Participate in packaging commodity reviews and supplier business reviews in order to recommend projects to reduce risk, lower cost, or meet new regulatory requirements
Supplier Owned - Environmental, Regulatory, Hardware & Trade Compliance - Understanding of in-country regulatory, environmental, hardware, and trade compliance requirements for each part in the BOM (including 3rd party devices) to guide Engineering team during part selection for both NPI and sustaining programs.
- Own supplier deliverables and obtain supplier documentation required to meet in-country regulatory, environmental, hardware, and trade compliance requirements to support global expansion.
- Act as the escalation point for unresolved supplier compliance documentation (e.g., material declarations), ensuring timely and accurate supplier submissions for part qualification.
- Partner cross-functionally to shape and improve Supplier Engineering processes and procedures related to material regulation, compliance, packaging, and labeling.
Supplier Quality & Corrective Action Leadership- Serve as the Endoluminal Supplier Engineering representative to Intuitive corporate CAPA teams for escalated or cross-BU quality issues.
- Instruct SCAR training and other training for the Endoluminal Supplier Engineering team, providing mentoring to strengthen problem-solving rigor and consistency.
- Develop a master database for Intuitive owned equipment located at suppliers and ensure suppliers have appropriate PMC, spares and track when replacement parts or firmware updates are needed.
QualificationsRequired Skills and Experience- Demonstrated ability to partner effectively with Quality, Regulatory, Environmental, and Compliance organizations to develop new QMS procedures that can scale.
- 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
Required Education and Training - BS degree in Engineering or equivalent.
- Minimum 8 years related experience in Supplier Quality Engineering and/or Supplier Development or related field.
Working Conditions Preferred Skills and Experience - Knowledgeable how global regulations impact parts and finished goods manufactured by contract manufacturers for US, APAC, EMEA, EU
- Experience with environmental compliance frameworks including REACH, MDR, Conflict Minerals, Prop 65, Packaging, and Battery regulations.
- Familiarity with global trade, import/export requirements, and UL standards
- Familiarity with packaging requirements such as 21 CFR 820 (especially labeling, packaging, purchasing controls), EU MDR labeling & packaging expectations, UDI / GUDID requirements and traceability expectations
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
