Careers that Change Lives

A career at Medtronic is like no other. We’re committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

A Day in the Life

Medtronic is currently searching for a Senior Supplier Quality Engineer to join our growing Affera team at the Billerica facility. You’ll play a crucial role in supporting our Cardiac Ablation Solutions business unit by ensuring that our suppliers deliver high-quality parts, materials, and services and maintaining our high-quality standards.

Key Responsibilities:

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
• Evaluate suppliers' internal functions to assess overall performance and provide feedback.
• Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization).
• Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
• Manage the Approved Supplier List, including administrative work in MAP Agile.
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• Improve suppliers' performance and reduce escapes to manufacturing.
• The job requires travel to visit suppliers within the United States and internationally.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree in engineering or related field
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have:

• Experience in Printed Circuit Board manufacturing and cable manufacturing (EE preferred) for the Capital/Hardware SQE position.
• Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter/Disposable SQE position.
• Medical device manufacturing industry experience, preferably ISO 13485.
• Lead auditor experience.
• Hands-on experience with SAP, Trackwise, Agile change management.
• Ability to manage tasks and projects under tight deadlines with a sense of urgency.
• Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
• Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
• Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
• Engage in changes and advocate for inclusions/diversity.