Sr. Product Test Engineer - Product Verification & Reliability Engineering

Careers That Change Lives

Do you have the following skills, experience and drive to succeed in this role Find out below.

In this exciting role as a Senior Test Engineer in the product design verification & reliability engineering group of the Mechanical Engineering department, 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.

The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including hardware product verification & reliability test related work products to ensure compliance.

Provides test area with parameters for sample testing and specifies tests to be performed. Compiles 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.

A Day in the Life

• Plan and execute large and complex medical device product development programs design verification and reliability test strategy 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.
• Plan and execute product design verification and reliability demonstration understands and applies 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 of 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 and verification, process validation 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.
• Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities as applicable.
• Participates on project teams and technical review boards and leads change control evaluations. Coordinates quality decisions between different quality and engineering groups.

Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

• Driving clarity and consistency in documentation.
• Leading CAPA projects and assisting post market analysis.
• Participating in support of external and internal regulatory audits and inspections as applicable.
• Driving Process improvement activities.
• Performs other related duties as assigned.

Must Have : Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor’s degree in engineering or science with 4+ years of work experience in medical device development and / or development quality

Master’s Degree in Engineering or Science with 2+ years of work experience in medical device development and / or development quality

Nice to Have

• Experience working in a regulated industry (e.g., FDA-regulated)
• Master’s Degree in Engineering, Quality, Regulatory, or related.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 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., MiniTab, Weibull ++, etc.)
• 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-task, prioritize, meets / exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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

ADA-United States of America)

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.

Learn more about our benefits here.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal / local regulations and may vary by experience, certification / education, market conditions, location, etc.

Additional Information

• Posting Date : May 23, 2024
• Travel : Yes,
• Salary Min : 95600
• Salary Max : 143400

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