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Sr. Manager, Reliability & Design Control

Carlsbad, CA 92008
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Sr. Manager, Reliability & Design Control


Carlsbad, California, United States

Requisition #:


Post Date:

Jul 23, 2020

**Careers that Change Lives**

Medtronic is a global leader in medical technology, services, and solutions that take on the healthcare industry's greatest challenges.You will be a member of Respiratory Medical Services in Minimally Invasive Therapies business group that supports design and development of ventilation products that save patient lives and impact patient outcomes.Come for a job, stay for a career.


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

**PATIENT MONITORING AND RECOVERY** focuses on improving outcomes associated with respiratory compromise, deep vein thrombosis, nutritional insufficiency, and healthcare associated infections.

**A Day in the Life**

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

The Sr. Manager, Reliability Design Control Engineeringis responsible for leading and managing quality assurance of medical device products and processes for the Ventilation business in Medtronics Respiratory Intervention Business Unit.This position, based in Carlsbad, CA (San Diego), shall manage design quality, reliability and compliance activities of critical care ventilators, portable ventilators product that are currently market released or in-development.

With an emphasis on Reliability Engineering principles, the manager will focus on improving product quality, product reliability, product safety, and compliance with applicable regulations (domestic and international)

Problem solving and active management of ambiguous situations is needed. Success is measured in terms of the frequency and scale of product reliability and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement and personnel development, the Sr. Manager, Reliability (QA) ensures that team and project personnel produce high quality, reliable products, compliant documentation and improved QMS processes.

This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of design controls and standards.

As a manager within the Quality organization this position will provide leadership, guidance, and oversight of the companys quality system elements and will facilitate communication and coordination among project teams and between project teams, functional departments, senior staff and the steering committees.


+ **Lead a team of design quality engineers to support all design control activities for CDP, PDP and new development projects for critical care and ventilators. . Ensure effective design transfer between development and manufacturing**

+ **Serves as Design Quality/Reliability expert for complex new/sustaining product development projects as well CAPAs and FI for post-market issues.**

+ **Provides subject matter expertise to internal employees and cross-functional teams with regard to reliability principles. Build and drive an effective reliability program and Reliability Engineering discipline in our day to day operations by leveraging statistical methods, statistical process control and sampling plans**

+ **Provide guidance and leadership in QMS development processes and post-market processes, with emphasis on product quality and reliability. Effectively partner with RD to define deliverables and troubleshoot technical issues.**

+ **Provide strategy and structure for product quality support including complaint trending, escalation, CAPA investigation and execution, Failure investigation, Risk assessment and documentation, as appropriate.**

+ **Work collaboratively and cohesively with cross functional teams and provide training/guidance on Requirement Engineering, Design Specifications, Technical Design Reviews,** **Design assessments and best practices in product development**

+ **Collaborate with new sustaining development quality, operations quality, post-market vigilance to ensure quality and compliance in ventilation products and processes.**

+ **Interact with FDA inspectors and auditing body agencies during audits.**

+ **Manage department resource allocation across multiple product lines. Drive change, demonstrate effective decision making, and provide direction for quality operations. Provide guidance and development opportunities for department employees.**

+ **Oversee the quality and compliance aspects of product service and repair operations for ventilators and maintain ISO-13485 certification.**

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 7 - 10years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience

**Nice to Have**

+ **BS in Electrical/Mechanical Engineering with strong background in Reliability Engineering**

+ **Masters in Reliability Engineering Preferred**

+ **10 years of progressive design quality engineering/management responsibility or equivalent work experience and/or professional qualifications. Medical Device experience is preferred**

+ **Familiar with reliability analysis and test methods**


+ **Working knowledge of design controls, Reliability planning, Reliability Analysis and technical writing.**

+ **Excellent analytical, technical, and problem-solving skills.**

+ **Experience with design controls and product development processes**

+ **Extensive, expert level knowledge of Reliability Engineering principles including error budgeting, failure investigation, PM intervals, etc.**

+ **Working knowledge and experience in statistics and building different models/views is a plus. Skilled in statistical methods, statistical process control and sampling plans** .

**Other Skills:**

+ **Good written and oral communication skills**

+ **Good interpersonal skills**

+ **Effective coaching and mentoring skills**

+ **Good decision making skills**


**Partners closely with Quality leaders, may have direct reports**

**Interacts with all departments and management personnel**

**Interacts with customers, suppliers, regulatory agencies and notified body representatives**

**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: 2020-07-28 Expires: 2020-10-04
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Sr. Manager, Reliability & Design Control

Carlsbad, CA 92008

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