Medtronic
Sr Quality Engineer-New Product Introduction
Juncos, Puerto Rico, United States of America · Senior
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About the role
- This role also provides oversight to equipment and process validation activities at the site.
- The Senior Quality Engineer is responsible for supporting product and process quality within a regulated manufacturing environment.
- Please keep the following in mind: Apply only through official Medtronic channels.
Responsibilities
- Lead and support continuous improvement projects and quality initiatives that enhance product quality, process performance, and compliance.
- Develop, implement, maintain, and improve quality standards and protocols for materials, components, and finished products.
- Partner with engineering and manufacturing teams to ensure quality requirements are effectively integrated into manufacturing processes and operations.
- Design and implement inspection, testing, and evaluation methods to verify product quality, equipment performance, and process effectiveness.
- Conduct statistical analysis and quality assurance activities to evaluate product and process performance, identify trends, and support data-driven decision making.
- Provide technical quality support across design, incoming materials, production control, product evaluation, reliability, inventory control, research and development, or other quality-related areas as needed.
- Experience applying quality tools and methodologies to support investigations, corrective actions, and process improvements.
Requirements
- Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience
- OR Master's Degree and a minimum of 2 years of relevant experience
- Experience collaborating with cross-functional teams including engineering, manufacturing, and quality organizations.
- Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience; OR Master's Degree and a minimum of 2 years of relevant experience; OR PhD.
Nice to have
- Experience with Design Controls, Risk Management, and quality engineering activities throughout the product lifecycle.
- Experience leading cross-functional projects and influencing stakeholders in a matrixed environment.
- Expertise with statistical analysis tools including Minitab, Statistical Process Control (SPC), and trend analysis.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with validation lifecycle management, change control, quality risk management, reliability engineering, product performance testing, and mentoring engineers or project teams.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- Physical Job Requirements
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Compensation
- Benefits & Compensation
Benefits
- Experience supporting quality engineering activities within a regulated manufacturing or medical device environment.
Company info
- U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact.
- Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers.
Visa & Work Authorization
- U.S. Work Authorization & Sponsorship
This listing is sourced directly from Medtronic's careers page and normalized into a canonical job model.