1+ months

Engineering Program Manager

Fridley, MN 55432
Engineering Program Manager


Fridley, Minnesota, United States

Requisition #:


Post Date:

Aug 31, 2021

**Careers That Change Lives**

A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as an **Engineering Program Manager** you will have responsibility for project management and leadership for the escalation and resolution of issues associated with the performance of released Deep Brain Stimulation and Spinal Cord Stimulation products. You will monitor and ensure that quality records like formal investigations, risk assessments, issue assessments, etc. are completed in a timely manner and in accordance with our quality procedures.

**A Day in the Life**

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

+ May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

+ Oversees the investigation and evaluation of existing technologies.

+ Guides the conceptualization of new methodologies, materials, machines, processes or products.

+ Monitors documentation maintenance throughout all phases of research and development.

+ Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

+ Selects, develops and evaluates personnel to ensure the efficient operation of the function.

+ Responsible for released product performance issue escalation, reporting and resolution including critical product quality and segregation decisions based on known information. Champion excellence for released product quality, reliability, and patient safety.

+ Lead cross functional project teams for issue investigation analysis and resolution process to meet regulatory requirements and business goals. Resolution may include initiating global field corrective actions. Members may include Design, Medical Safety, Manufacturing, Supply Chain, Quality, Reliability, Regulatory and Marketing functions. Exercise sound judgment within defined practices and policies, including CAPA policies and procedures.

+ Accountable for all aspects of work product including written documentation, interpretation and use of policies, procedures, regulations, and standards.

+ Responsible for developing, communicating, and documenting investigation plans associated with Nonconformances, complaint investigation and the Fielded Product Action Assessment processes.

+ Strong written and verbal communication skills. Able to prepare timely concise, unambiguous, fact-based summaries and decision rationales, suitable for review by inspectors and regulators

+ Facilitate good cross-functional and cross project team communication, collaboration, and coordination to ensure successful completion of issue investigation and resolution.

+ Applies knowledge of Quality System, standards, and regulations to plan and manage quality solutions on a global basis.

+ Travel requirement: Less than 10%

**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**

Bachelors Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industry.

**Nice to Have**

+ Well-developed critical thought process, able to analyze technical detail and provide solution process. Strong competencies in judgment and problem solving.

+ Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.

+ Quality or reliability engineering experience in product development or high-volume manufacturing.

+ Has working experience with reliability tools, including failure mode and effect analysis, statistical analysis, risk analysis, inspection test method validation and design test verification and validation.

+ Highly developed skill set in project leadership practices, including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes. Excellent downward, lateral, and upward communication skills.

+ Skilled at facilitation, consensus building and conflict resolution with peers.

+ Demonstrated track record of successfully leading projects to completion under tight time constraints.

+ Proficient in word processing, spreadsheets, presentation, and project management tools.

+ Experienced practitioner of Design for Reliability and Manufacturability (DRM)

+ Knowledge and experience with Lean Sigma tools.

+ Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices.

+ FDA audit support 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. 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: 2021-09-02 Expires: 2021-11-07

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Engineering Program Manager

Fridley, MN 55432

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