A Day in the Life

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.

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it's like to work at a company with an exciting product pipeline entire of patented inventions driving innovation in the healthcare space.

The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that will enhance lives as we embody a culture of accountability and trust.

Over the past 20 years, we have become the global market leader in three key segments image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in tissue health and balloon sinus dilation.

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.
• CAPA (Corrective and Preventive Action): Proficiency in leading lower risk CAPA processes to identify, investigate, and resolve quality issues; Show proficiency with the use of at least 2 Root Cause Analysis tools: fishbone, 5 whys; Being able to explain the differences between containment, correction, corrective action and preventive action;
• Project Management: Being able to lead projects and establish project plans
• Internal and External Auditing: Skills in participating in the backroom during and/or leading internal audits and managing external audits by regulatory bodies and notified bodies;
• Risk Management: Knowledge and application of risk management processes and standards independently such as ISO 14971 for identifying and mitigating risks associated with medical devices. Being able to explain the risk management structure of a product. Be able to establish and make improvements to risk management processes based on standards such as ISO 14971 and industry practices for identifying and mitigating risks associated with medical devices.; being able to train others in the risk management process and applicable standards; being able to establish the risk management structure for a product; Being able to execute Health Risk Assessments (HRA) and explain the difference between P1, P2, severity, sequence to events coach others through the process; being able to provide guidance on statistically relevant approaches to perform the HRA; being able to establish P1, P2, severity, sequence of events for a novice product (new to the market); being able to establish, execute and communicate a remediation plan
• Internal Supplier Quality Management: Evaluating and establish criteria for internal supplier quality to ensure that materials and components meet regulatory and quality standards.
• Test Method Validation Lead the planning and execution of test method validations following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to coach team members on the identification of challenge samples. Being able to provide a rationale and a plan for the TMV remediation, as needed.
• Equipment Qualification Lead the planning and execution of equipment qualifications following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to explain the differences between IQ/OQ/PQ. Being able to collaborate with R&D on the identification of challenge samples.
• Process Validation - Lead the planning and execution of process validations following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to explain the differences between IQ/OQ/PQ. Being able to collaborate with R&D on the identification of challenge samples.
• Design verification and design validation Being able to identify when design verification and/or validation are required per the established procedures. Being able to explain the difference between design verification and design validation. Being able to identify the statistically relevant sample size and document the rationale. Being able to collaborate with R&D on the identification of challenge samples.

Must Have: Minimum Requirements

• Bachelor's degree required in Mechanical Engineering, Electrical Engineering, Computer Engineering, or a technical field
• Minimum of 4 years of Quality Engineering experience or advanced degree with a minimum of 2 years relevant experience

To Be Successful in this role:

• Minimum of 8 years of Quality Engineering experience or advanced degree with a minimum of 6 years relevant experience
• Experience in the medical device, in-vitro diagnostics or pharma industries
• Strong knowledge of 13485/FDA 21 CFR 820 and ISO14971
• Experience with statistics and statistical techniques as it applies to sample size determination, trends, risk management related calculation such as P1 and P2, etc.
• Experience with project/program management

Nice to Have

• Strong knowledge on project/program management techniques or PMP certification or equivalent
• Experience in test automation and with statistical process controls
• Black Belt or Master Black Belt certification
• Experience with statistical process controls
• Must be self-motivated to complete assigned tasks on time.
• Must be able to multitask on several assigned projects/assignments
• Strong communication and presentation skills

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.

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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.

Salary ranges for U.S (excl. PR) locations (USD):$96,800.00 - $145,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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-