Prin Quality Engineer.

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.

Seeking a highly skilled and experienced Principal Quality Engineer to provide technical leadership across complex investigations advanced problem-solving initiatives validation programs and strategic quality improvement efforts. This role will serve as a key partner to Quality Operations Manufacturing Engineering Regulatory Affairs and Supply Chain teams driving robust root cause analysis CAPA effectiveness risk management and quality engineering excellence.

The ideal candidate will be a self-starter with strong analytical and leadership skills capable of solving complex technical challenges while influencing cross-functional teams and driving sustainable improvements. This position will also serve as the Quality representative for capital investment projects equipment qualifications process validations and implementation of new manufacturing technologies. The successful candidate will provide expert guidance to ensure quality requirements are integrated throughout project planning and execution while strengthening compliance operational performance and inspection readiness. Through technical mentorship strategic leadership and hands-on problem solving this role will play a critical part in advancing the sites quality culture reducing risk and supporting long-term business objectives.

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

• Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.

Nice to have:

• Demonstrated expertise in advanced problem-solving methodologies such as DOE DMAIC Shainin Kepner-Tregoe 8D and statistical analysis to resolve complex manufacturing and quality issues.
• Experience leading capital investment projects process validations (IQ/OQ/PQ) equipment qualifications automation initiatives and implementation of new manufacturing technologies within a regulated environment.
• Strong background in risk management and regulatory compliance including PFMEA DFMEA ISO 14971 FDA ISO 13485 and support of regulatory inspections and external audits.
• Proven ability to influence cross-functional teams and senior leadership providing technical mentorship while driving strategic quality operational excellence and continuous improvement 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:Recognized expert managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager. Coaches reviews and delegates work to lower level specialists.

Organizational Impact:Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity:Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation. Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.

Communication and Influence:Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement and influence decision-making.

Leadership and Talent Management:Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.

Required Knowledge and Experience: Requires a Baccalaureate degreeand minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Minimum Requirements:

• Education: Minimum bachelors degree in engineering or a related technical field. Advanced degree is preferred
• Regulatory Knowledge: In-depth knowledge of FDA regulations ISO 13485 ISO 14971 and other relevant standards.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Certifications: Certified Quality Engineer (CQE) Six Sigma Green Belt or equivalent certification.
• Communication: Excellent written and verbal communication skills with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications:

• Certifications: Lean or Sig Sigma Black Belt is preferred.
• Experience: Regulated engineering field
• Industry Experience: Medical device industry.
• Technical Skills: Proficient in quality management systems risk management regulatory compliance and statistics.

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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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).