Senior Pre-Market Quality Engineering Manager – Brooklyn Park, MN (Hybrid) - Medtronic

We anticipate the application window for this opening will close on - 29 Nov 2024At 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 LifeCareers that Change LivesA career at Medtronic is like no other.
We’re purposeful.
We’re committed.
And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Sr.
Pre-Market Quality Engineering Manager in Cardiac Surgery (CS), you will lead the Cardiac Surgery Pre-Market Design Assurance Engineering team based in Brooklyn Park, Mounds View, and Dexter Michigan.
This team includes design assurance engineers supporting pre-market and sustaining, quality core team members, supplier quality assurance, software quality assurance and people manager.
Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio.
Key Technologies:• Surgical heart valves• Cardiac OR solutions (e.g., blood management, cannulae)• Extracorporeal life support• Coronary artery bypass grafting (CABG) solutionsLead Pre-Market Quality including Support new product development and released product engineering, pre-initiation quality input for staffing/strategy, support Quality Strategy for new projects, Support Risk Management architecture/etc developed by engineers, Support DRM targets (challenging how/why they are set the way they are), Support Design and Phase reviews/ PRC, Support Design Transfer, Support Audit support for Design Controls, Approve all RM documents, design phase reviewsResponsible for budget of team (project charging), enter actuals and planned FTE’s through AOP processProvide direct supervision, coaching and mentoring to the design assurance engineers, quality core team members and people manager in your team.  This includes work direction, priority and objective setting, development opportunities, training, and performance management.Plans, directs and implements quality related aspects of the company's design and development of new products within the portfolio.
Ensures compliance in development processes.May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.Collaborate with R&D engineering, our product management organization and partner engineering teams in making product design decisions.Drive establishment of Quality, Reliability, and product development strategies to improve safety, reliability, and usability of the product family for our patients.Partner with RD on development of test strategiesEnsures risk management processes are fully integrated into development processes and support production and process controls.Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulationsManage performance, develop talent, engagement and inclusion, communicate business and operational developments, plan, prioritize and/or direct the responsibilities of direct reports.Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.Accountable for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.MUST HAVE - MINIMUM REQUIREMENTS: TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUMEBachelor’s degree in engineering, science or a technical disciplineMinimum of 7 years of relevant experience in Engineering and 5 years of managerial experience, OR advanced degree in Engineering, and/or Quality with a minimum of 5 years of relevant experience with 5 years of managerial experienceNice to Have Prior experience in or demonstrated strong working knowledge of global medical device regulations and requirements.Experience dealing directly with U.S.
FDA and/or other medical product competent authorities/regulatory authorities.Bio-medical engineering degreeMaster’s degree in engineering with 5+ years engineering experienceEngineering experience with medical devices, specifically disposable devices.Thorough working knowledge of medical device industry product risk management regulations and standardsUnderstanding of heart anatomy and human/blood physiologyDemonstrated perfusion product application knowledgeStrong communication skills (written, verbal, listening (with all levels of the organization).
Strong interpersonal, and problem-solving skills.Experience supporting cross-functional and cross-regional teams in a matrixed org.
developing collaborative relationships.Identifies and resolves issues in a proactive, creative, and timely fashion. About MedtronicTogether, 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 RequirementsThe 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).  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)  here.The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.  Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience. Physical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$160,000.00 - $240,000.00This 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).Medtronic benefits and compensation plansAbout MedtronicWe 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 90,000+ 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.SummaryLocation: Brooklyn Park, Minnesota, United States of AmericaType: Full time