1+ months

Product Engineer - Principal

Miami Lakes, FL 33016
Product Engineer - Principal


Mounds View, Minnesota, United States

Requisition #:


Post Date:

Dec 03, 2019

Careers that Change Lives:

Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

The Principal Product Engineer serves as a subject matter expert by providing leadership and Sourcing support for sustaining and improving projects in Post Market. The individual will act as a subject matter expert and provide guidance to the business and the external suppliers in executing against Medtronic Quality system elements as required to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronics quality and compliance requirements. This individual will ensure Sourcing-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

A Day in the Life:

You are a self-motivated person, determined to succeed.

You have strong analytical and conceptual thinking, working through the details while seeing the big picture.

You have a desire to learn and improve the current technology and processes, driving for creative solutions and sustainable results.

Top responsibility is for the quality of our products which support the monitoring and follow up of patients with implanted cardiac devices.

You understand the importance of product performance, functions, and product use environments to appropriately and strategically apply technical knowledge to drive the suppliers Manufacturing requirements and improvements

You work collaboratively with Design Engineering, Development, Test Engineering, Regulatory Affairs, and other cross-functional partners

As a team member, youre also responsible for continuous improvement and ensuring we have industry-leading practices.

You lead process improvement projects and develop shared best practices to drive functional excellence


Understands therapy (clinical) performance, disease states, product function(s), and product use conditions to appropriately and strategically apply supplier selection, development, component and finished product qualification and production control plans.

Define supplier objectives, Design and Manufacturing requirements, partner with suppliers to ensure components are designed and manufactured for reliability, manufacturability, and cost reduction via component and finished product specifications. Ensure supplier feedback is included in the development process.

Previous Medical Device Manufacturing experience is preferred with proven abilities to establish, communicate, implement and execute on Remediation initiatives to ensure the Mfg. meets the Regulation and Medtronic requirements for Compliance and Patient safety.

Define product qualification strategy as it relates to changes to supplier related processes in production, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component and Finished good engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.

Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.

Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause. Assure compliance to procedures and timely completion of CAPAs and audit findings.

Responsibilities include Project Management and leading cross-functional improvement initiative teams, leading Design for Manufacturability and Assembly (DFMA) thinking and work practices to demonstrate functional excellence.

Understanding of Manufacturing Process: advantages/disadvantage of various manufacturing methods for different commodity types, manufacturability, assembly, relation to design specifications, up and down requirements flow, traceability, and process control

Ability to interpret and contribute towards Engineering Process: design intent, risk management, therapeutic design functionality, develop qualify implement controls

Class II and III medical devices and regulations to include ISO13485, ISO9001 and FDA CFR.

Utilizing development protocols including Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, and Test Method Validations (TMV).


Bachelors Degree in Electrical Engineering or Mechanical Engineering, Reliability Engineering, Systems Engineering or other Technical Discipline

Seven (7) or more years of experience (with Bachelor's) or Five (5) or more years (with Master's)

Nice to Have:

Deep understanding and application of Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, Test Method Validations (TMV), Control Plans, Risk Management (DFMEA, PFMEA), External regulations and standards to include ISO13485, ISO9001, ISO 14971 and FDA CFR 21 part 820.

Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls

**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. Lets 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.


Posted: 2019-12-05 Expires: 2020-02-09

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Product Engineer - Principal

Miami Lakes, FL 33016

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