Senior Supplier Quality Engineer - Pre-Market

Medtronic•Indianapolis, IN

1d•Remote

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Job Title: Sr Supplier Quality Engineer: Pre-Market for Cranial & Spinal Technologies Remote We are seeking a committed professional to join our team. This position is remote within the U.S., with a strong preference for candidates located in the Midwest (ideally Indiana) to support collaboration with regional suppliers. The role requires approximately 50% travel throughout the Midwest to engage directly with suppliers and support quality initiatives. Must have a valid driver's license. We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for leading a Pre-Market Supplier Quality Engineering team for the CST OU. The Supplier Quality team primarily supports NPI (New Product Introduction) projects and supplier management activities and processes. The role encompasses both team leadership and individual contributor aspects to support the Supplier Quality goals and objectives. Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. CST is the market leader in spinal implants, robotics, and navigation. The scope of this position will primarily focus on Spine and biologics hardware and procedures but may have responsibilities for other portions of CST. We believe that when people from different cultures, genders, and points of view come together, innovation is the result—and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. In general, the following responsibilities apply for the Senior Supplier Quality Engineer role. This includes, but is not limited to the following: Provides Pre-Market Supplier Quality Engineering support to New Product Introduction (NPI) working in partnership with the project teams and Post-Market Supplier Quality Teams to deliver quality parts, materials, and services, which allow Medtronic to provide customers with the highest quality and reliable products. Drives supplier requirements by collaborating with Product Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk. Partners with suppliers to ensure parts are designed for reliability, manufacturability, and cost. Qualifies suppliers according to company standards including, but not limited to, supplier segmentation, early supplier involvement, supplier selection, approved supplier list requirements, and supplier agreements. May perform supplier audits (QMS and process audits) to ensure good manufacturing practices (GMP) and quality standards are met. This may include audit planning, leading audit execution, audit reporting, and follow-up on audit findings with suppliers. Participates in Design Transfer activities to ensure successful transfer to external suppliers including CM/OEM. Leads part qualification strategy (PPAP or other) and partners with suppliers to develop and execute the qualification plan. Performs process development work with suppliers to deliver highly capable parts and processes. Applies principles of physics, chemistry, and material behaviors in the evaluation of supplier processes. May provide technical expertise on process validations (IQ/OQ/PQ) and special processes. Works with suppliers and internal Receiving Inspection teams as needed on inspection and testing methods, MSA/TMVs, product acceptance sampling strategies, and control plans. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Supports supplier performance monitoring as needed. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. May support non-conforming material reports, supplier change requests, and quality performance reviews as needed. Performs and reviews Corrective Actions and Preventive Actions (CAPA) to investigate issues, identify root cause, and apply effective actions to prevent recurrence. Applies continuous improvement mindset and techniques to enhance quality system and business processes. Deploys Design for Reliability and Manufacturability (DRM) and Lean Six Sigma (LSS) tools as applicable. Develops relationships with key stakeholders, navigates matrixed organization, recognizes and adjusts to diverse cultures, and establishes trust, credibility, and respect between both internal and external partners. May train, mentor, and coach lower-level team members to share knowledge, build skills, and enhance talent development. As a Sr. SQE level, you will work independently under limited supervision as a seasoned individual contributor addressing difficult challenges. Problem-solving is in-depth, requiring innovative solutions, process improvements, and project or change management skills.

Requirements

Bachelors degree in Engineering required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

Nice To Haves

Bachelors or Masters Degree in Engineering
Knowledge of DRM, Lean, and 6 Sigma principles
Knowledge of GD&T
Knowledge of Risk Management (PRA, DFMEA, UFMEA, PFMEA)
Experience with Validation (IQ, OQ, PQ, TMV)
Knowledge and experience with manufacturing assembly processes and inspection/testing methods
Thorough knowledge and experience with NPI Processes
Excellent organization, planning, technical writing, communication, and presentation skills
Lead-auditor training and certification (ISO 13485, etc.)
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.

Responsibilities

Provides Pre-Market Supplier Quality Engineering support to New Product Introduction (NPI) working in partnership with the project teams and Post-Market Supplier Quality Teams to deliver quality parts, materials, and services, which allow Medtronic to provide customers with the highest quality and reliable products.
Drives supplier requirements by collaborating with Product Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk.
Partners with suppliers to ensure parts are designed for reliability, manufacturability, and cost.
Qualifies suppliers according to company standards including, but not limited to, supplier segmentation, early supplier involvement, supplier selection, approved supplier list requirements, and supplier agreements.
May perform supplier audits (QMS and process audits) to ensure good manufacturing practices (GMP) and quality standards are met. This may include audit planning, leading audit execution, audit reporting, and follow-up on audit findings with suppliers.
Participates in Design Transfer activities to ensure successful transfer to external suppliers including CM/OEM.
Leads part qualification strategy (PPAP or other) and partners with suppliers to develop and execute the qualification plan.
Performs process development work with suppliers to deliver highly capable parts and processes.
Applies principles of physics, chemistry, and material behaviors in the evaluation of supplier processes.
May provide technical expertise on process validations (IQ/OQ/PQ) and special processes.
Works with suppliers and internal Receiving Inspection teams as needed on inspection and testing methods, MSA/TMVs, product acceptance sampling strategies, and control plans.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Supports supplier performance monitoring as needed.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
May support non-conforming material reports, supplier change requests, and quality performance reviews as needed.
Performs and reviews Corrective Actions and Preventive Actions (CAPA) to investigate issues, identify root cause, and apply effective actions to prevent recurrence.
Applies continuous improvement mindset and techniques to enhance quality system and business processes.
Deploys Design for Reliability and Manufacturability (DRM) and Lean Six Sigma (LSS) tools as applicable.
Develops relationships with key stakeholders, navigates matrixed organization, recognizes and adjusts to diverse cultures, and establishes trust, credibility, and respect between both internal and external partners.
May train, mentor, and coach lower-level team members to share knowledge, build skills, and enhance talent development.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)