Prin Quality Engineer
A Day in the Life
Principal Supplier/Manufacturing Quality Engineer (SQE/MFG)
Summary
The Principal Supplier/Manufacturing Quality Engineer is responsible for:
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Driving exceptional component quality through his/her expertise in supplier selection strategy, supplier management, component qualifications.
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Supporting Medtronic internal assembly/manufacturing process qualification and validation.
This role assists new product development teams and suppliers in providing components that consistently meet specifications, quality and reliability, delivery, and cost requirements. Success requires broad knowledge of new product development and manufacturing methodologies, design control systems and quality management practices.
Primary Responsibilities
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Conducts supplier selection, assessments, quality system audits and supplier part and process qualification (PPAP).
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Responsible for the component qualification process, FAI, and manufacturability assessment.
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Lead design for manufacturability and assembly (DFMA) discussion with Medtronic design team and supply base.
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Assures supplier compliance to relevant quality and regulatory standards.
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Provides feedback to design teams regarding suppliers’ capabilities, tolerance, specifications, measurement, and test methodologies.
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Is a liaison between NPD teams and suppliers on technical and/or quality issues.
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Works directly with suppliers to achieve goals including some travel on short notice.
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Assures Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the Supplier CAPA (SCAPA) process.
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Co-lead with R&D Manufacturing Engineers on Process Failure Mode and Effect Analysis (PFMEA), developing Process Control Plans (PCP) and Process Validations (IQ/OQ/PQ).
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Is informed about advancement in area of expertise and is knowledgeable about new rules, regulations, and standards.
Required Skills and Knowledge
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New Product Development Processes
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Ability to work with a supplier on requirements, specifications, process improvements, and capability studies.
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Background in Six-Sigma, LEAN, FTQ, DFSS and related quality management tools
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Familiar with ISO 9001 or ISO 13485/820 requirements
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Ability to resolve complex problems requiring detailed data analysis, calculation, or experimentation.
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Expertise/experience in Magnetics and Electrical/Electronics (e.g. PCBA, Flex Circuits, etc.) and/or expertise/experience in Injection Molding, Machining, Die Cast, Stamping, Extrusion, MIM, etc
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Technical abilities in understanding the interaction with components and assembly (e.g. tolerance analysis, fit and finish, functionality, etc.).
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Ability to determine which measurement instrument to use in various situations based on considerations such as the characteristic to be measured, the required accuracy level, and uncertainty.
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Proficiency in Minitab or JMP and working knowledge in statistics (e.g. MSA, Normalilty, Capability, Hypothesis Testing, DOE, etc.).
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Effective verbal and written communication
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Bachelor’s degree in electrical, Computer, Electronics Engineering, or related field + 6 years’ experience or Advanced Degree + 4 years’ experience.
- Bachelors degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Nice to Have
- Experience in Production Part Approval Process (PPAP), Process Validations, Design for Manufacturability and Assembly (DFMA), Process Failure Mode and Effect Analysis (PFMEA).
- Medical Device hardware/software/disposables experience is preferred.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
