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Engineering Manager (Quality)- Santa Rosa, CA

San Francisco, CA 94103
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Engineering Manager (Quality)- Santa Rosa, CA


Santa Rosa, California, United States

Requisition #:


Post Date:

Apr 27, 2022

**Engineering Manager (Quality)**

**Req Number 2200026T**

**Location Santa Rosa, CA or Hybrid (2-3 days/week onsite in Santa Rosa, CA)**

The Quality Engineering Management position is primarily responsible for overseeing product development activities forCoronary Renal Denervation (CRDN)in a global marketplace. This position is accountable for delivering high reliability and quality products through efficient execution of product development activities, change management and meeting quality objectives/metrics for the business. This position is also responsible for ensuring that the product development activities follow all applicable internal, corporate, and regulatory standards or requirements.

This positon will involve staffing, developing, and resource planning for Design Assurance Engineers, and technicians. Additionally, this role may serve as a Quality Core Team/Extended team member on new product development efforts.

This position may also lead or support Quality functional initiatives as well as Quality System improvement activities and Internal/External Audits.

**Coronary Renal Denervation**

Coronary Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.

**A Day in the Life**

+ Provide design quality leadership for product development and design changes. Ability to look at the larger picture of the development project and influence the Core Team to assure quality objectives are met.

+ Provide direction for quality staff to define adequate design and supplier controls to new product development.

+ Build a strong quality engineering team by hiring qualified candidates, establishing, and actively managing performance expectations, and providing training opportunities to direct staff. Serve as a coach/mentor for cross-site Design/Quality Assurance Engineers

+ Supports quality assurance and quality improvement initiatives including supplier qualification, design assurance programs and design transfers.

+ Responsible for forecasting department headcount and justification/rational of headcount allocation. Recruit and hire quality staff.

+ Demonstrate high technical skills; apply sound engineering judgment, technical, statistical skills, and critical thinking in product development activities and resolution of quality issues. Creatively and effectively challenges status quo when developing and recommending solutions.

+ Provide Root cause investigation and corrective/preventive action support or ownership

+ Oversees the investigation and evaluation of existing technologies.

+ Directs the development of new concepts from initial design to market release.

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

**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 experience in Quality and/or Engineering OR Advanced degree in Engineering, Science or Technical field with 3+ years of experience in Quality and/or Engineering

**Nice to Have**

+ Prior experience managing, directing, and developing people or projects. (Highly Preferred)

+ Experience with medical device product development, design verification/validation/Test Methods, risk management, DRM, reliability engineering, process validation and Quality systems.

+ 3+ years of experience with 21CFR Part 820 and ISO 13485 and Quality system requirements in other geographies

+ 3+ years of experience with relative ISO and FDA regulations and Good Manufacturing Practices (GMP)

**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)

10 % of the Time (as needed)
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: 2022-03-08 Expires: 2022-06-06
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Engineering Manager (Quality)- Santa Rosa, CA

San Francisco, CA 94103

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