We anticipate the application window for this opening will close on - 25 Apr 2025

 

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.

A Day in the Life

In this exciting role as a Senior Product Test Engineer, you will be responsible for product verification and reliability test planning, designing, developing, and implementing testing methods and equipment for new product development and sustaining projects relating to infusion pump systems. This role is a part of the product Design Verification & Reliability Engineering group, which is in the Mechanical Engineering department of the Diabetes Operating Unit. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements, which include hardware product verification & reliability test related work to ensure compliance. Define test configurations and lab needs for sample testing and specifies tests to be performed. Compile data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for writing verification test plans and reports. This individual will ensure that all program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure product reliability and verification driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

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

• Plan and execute large, complex verification and reliability test strategies for medical device product development programs by collaborating and ensuring appropriate key interdependencies are understood and delivered upon by cross functional counterparts from design planning through design transfer for electromechanical hardware product development.

• Collaborate with systems engineering and product development teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces like electro-mechanical, electro-chemical sensors, embedded firmware and machine learning algorithms.

• Develop, coordinate and conduct technical product design verification and reliability demonstration – understand and apply basic product design verification methods & principles for developing design verification, and reliability test strategies. Lead the development, modification and design review of plans, reports, protocols, data summaries & record.

• Use statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations, root cause analysis, and verification and reliability demonstration activities.

• Partner and review risk management deliverables like design and process failure modes effects analysis (DFMEA/PFMEA) and Hazard Analysis.

• Utilize the risk management and robust design principles to understand essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development and develop test methodologies to demonstrate effectiveness.

• Assist supplier quality engineering and purchasing teams in vendor development and component engineering qualification activities, as applicable.

• Participate on project teams and technical review boards and leads change control evaluations. Coordinate quality decisions between different quality and engineering groups.  Effectively navigate & facilitate project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

• Lead CAPA projects and assist post market analysis.

• Participate in support of external and internal regulatory audits and inspections as applicable.

Minimum Requirements:

Requires a Bachelors degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Preferred Qualifications:

• Experience working in a regulated industry (e.g., FDA-regulated)

• Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.

• Master’s Degree in Engineering, Quality, Regulatory, or related.

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, IEC 60601-2-24 and MDD.

• Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports). 

• Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred)

• Experienced with statistical analysis of data (e.g. MATLAB, Minitab, Weibull ++, etc.)

• Experienced with data acquisition software (e.g. NI LabVIEW, etc.)

• Experienced with fixture design and 3D modeling software (e.g. SolidWorks)

• Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing

• Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions

• Ability to author technical reports, business correspondence and standard operating procedures.

• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.

• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.

• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.

• Self-Starter with a sharp focus on quality and customer experience.

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: Seasoned individual contributor.

Works independently under limited supervision to determine and develop approach to solutions.

Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.

Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.

Makes improvements of processes, systems or products to enhance performance of the job area.

Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.

May manage projects, requiring delegation of work and review of others' work product.

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):$101,600.00 - $152,400.00

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-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here.

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.