Supplier Quality Engineer II.

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

A Day in the Life

In this exciting role as Supplier Quality Engineer II you will be responsible for the management of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic with accountability to support changes to existing supplied products and processes as well as oversight of performance and improvement activities. While partnering with our CMs and OEMs including sub-tier suppliers as required this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers quality systems.
The individual is expected to be proficient in communication project management and troubleshooting complex medical devices involving mechanical electrical and software interactions. Hands-on experience with schematics system diagnostics and root cause analysis. Familiarity with medical device quality standards (ISO 13485 IEC 60601 IEC 62304) and structured problem-solving in a regulated environment.

Responsibilities may include the following and other duties may be assigned.

• Ensures that suppliers deliver quality parts materials and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams to deliver quality parts materials and services prevent defects and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards regulatory requirements and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy Approved Supplier List coordination Supplier Owned Quality deployment and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Nice to have:

• Strong technical background in medical device mechanical assembly processes
• Experience with injection molded components tooling considerations and molding-related defect analysis
• Strong knowledge of metrology & measurement techniques; statistical analysis (Ppk/Cpk standard deviation etc.) in Minitab measurement uncertainty GD&T Gauge Repeatability & Reproducibility
• Experience with sterile barrier packaging package integrity considerations and packaging-related validation support
• Hands-on experience with root cause analysis nonconformance investigation and structured problem-solving
• Familiarity with medical device quality systems and regulated product development/manufacturing environments including ISO 13485
• Ability to work cross-functionally with design manufacturing quality supplier and packaging engineering teams
• Strong interpersonal organizational and project management skills.
• Demonstrated communication skills both verbal and written.
• Computer skills in MS Office and ERP systems desirable.
• ASQ CQE CQA and/or CSQP certification
• First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
• Demonstrated track record of effectively influencing and negotiating with others and leading effective/successful change initiatives

TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy:Established and productive individual contributor.
Works independently with general supervision on larger moderately complex projects / assignments.

Organizational Impact:Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.

Innovation and Complexity:Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence:Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information status needs and issues in order to inform gain input and support decision-making.

Leadership and Talent Management:May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires a Baccalaureate degreeand minimum of 2 years of relevant experience OR Masters degree with a minimum of 0 years relevant experience.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Benefits & Compensation

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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1