Prin Quality Engineer.

Medtronic; Ciudad Juárez; Presencial; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Medtronic, a global leader in healthcare technology, seeks a Principal Quality Engineer to provide technical leadership across investigations, CAPA effectiveness, risk management, and quality improvements. The role partners with Quality, Operations, Regulatory Affairs, and Supply Chain to ensure quality is integrated into planning and execution.

The ideal candidate will have a strong analytical mindset, leadership skills, and experience with design, process validations, and manufacturing

Formación

• Requires a Baccalaureate degree in engineering, or a related technical field.
• Advanced problem-solving methodologies and statistical analysis experience.
• Experience with regulatory standards and CAPA processes.

Responsabilidades

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into finished goods.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Implements methods and procedures for inspecting, testing and evaluating products and production equipment.
• Conducts quality assurance tests and statistical analyses to assess quality and determine responsibilities for non-conforming products.
• Ensures corrective actions meet reliability standards and that documentation complies with requirements.
• Provides guidance on capital investment projects, equipment qualifications, and process validations.

Conocimientos

Quality engineering

Root cause analysis

CAPA

DOE

DMAIC

Shainin

Kepner-Tregoe

8D

Statistical analysis

Regulatory compliance

Educación

Bachelor's degree in engineering

Advanced degree preferred

Descripción del empleo

Onsite

Ciudad Juarez, Chihuahua, Mexico

Full time

R74553

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 95,000 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

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 site's 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 degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Minimum Requirements:

• Education: Minimum bachelor’s 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.

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).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

Life‑transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight‑driven care . Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here (https://www.e-verify.gov/employees) .

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