Engineering Manager - Design Quality Assurance at Medtronic
Los Angeles, CA 90001
About the Job
At 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 LifeMedtronic Diabetes helps people gain better control and awareness over their diabetes
We work in the challenging space where medical devices are in the hands of everyday people, and those people expect state-of-the-art technology to help make managing their diabetes easier and more connected.In this exciting role as an Engineering Manager, you will have responsibility for managing a team of hardware and process engineers involved in the development and commercialization of the new products for the Diabetes Group
In addition, you will act as a Quality Core Team Member you will have responsibility for being the focal point of Quality for Medtronic product and system development programs in the Diabetes business
You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products
In this role, you will represent the voice of quality by providing technical expertise to the Product Development activities and driving efficiency to the processes through various process improvements
This role will plan all quality deliverables, activities, resources, application of a rigorous approach in design, manufacturability, and reliability, and be the voice of quality throughout the development lifecycle.DiabetesThe Diabetes Group is working with the global community to change the way people manage diabetes
Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health. We value what makes you unique
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.Visit to see an overview of the products in our Diabetes product portfolio.A Day in The LifeResponsibilities may include the following and other duties may be assigned.Provide direct supervision, coaching and mentoring to the design and process development quality engineers 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.Serves as a primary focal point and contact for all quality aspects of a project
Represents and make decisions on behalf of quality on the core team.Maintains alignment and manages execution across all Global Quality disciplines.Collaborate with R&D, system 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.Provide leadership and guidance to create consistency in our architecture, interface, and designs that will enable platforms and future product expansion.Drive development of test strategies for complex systems, partnering with regulatory on strategies for emerging technology.Oversees the investigation and evaluation of existing technologies.Guides the conceptualization of new methodologies, materials, machines, processes or products. Ensures risk management processes are fully integrated into development processes and support production and process controls.Directs the development of new concepts from initial design to market release. Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.Manages feasibility studies of the design to determine if capable of functioning as intended.Monitors documentation maintenance throughout all phases of research and development.Regularly interacts with site leadership. Represents quality as a member of the development staff as well as serving on the quality staff.Selects, develops and evaluates personnel to ensure the efficient operation of the function.Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products.Lead external and internal regulatory audits and inspections as it pertains to design and development and sustaining.Must Have: Minimum RequirementsTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile
Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and/or engineering with 3+ years of managerial experienceORMasters Degree in Engineering or Science field with 3+ years of experience in quality and/or engineering with 3+ years of managerial experience.Nice to HaveExperience working in a regulated industry (e.g., FDA-regulated)Master’s Degree in Engineering, Quality, Regulatory, or related.Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applicationsWorking knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiativeExperience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus.Ability to author technical reports, business correspondence and standard operating procedures.Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians.Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.Self-Starter with a sharp focus on quality and customer experienceCertifications in Quality Engineering, Quality Management or Program Management.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):$136,000.00 - $204,000.00This 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.At Medtronic, most positions are posted on our career site for 3-7 days. SummaryLocation: Los Angeles, California, United States of AmericaType: Full time
You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic Diabetes helps people gain better control and awareness over their diabetes
We work in the challenging space where medical devices are in the hands of everyday people, and those people expect state-of-the-art technology to help make managing their diabetes easier and more connected.In this exciting role as an Engineering Manager, you will have responsibility for managing a team of hardware and process engineers involved in the development and commercialization of the new products for the Diabetes Group
In addition, you will act as a Quality Core Team Member you will have responsibility for being the focal point of Quality for Medtronic product and system development programs in the Diabetes business
You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products
In this role, you will represent the voice of quality by providing technical expertise to the Product Development activities and driving efficiency to the processes through various process improvements
This role will plan all quality deliverables, activities, resources, application of a rigorous approach in design, manufacturability, and reliability, and be the voice of quality throughout the development lifecycle.DiabetesThe Diabetes Group is working with the global community to change the way people manage diabetes
Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health. We value what makes you unique
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.Visit to see an overview of the products in our Diabetes product portfolio.A Day in The LifeResponsibilities may include the following and other duties may be assigned.Provide direct supervision, coaching and mentoring to the design and process development quality engineers 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.Serves as a primary focal point and contact for all quality aspects of a project
Represents and make decisions on behalf of quality on the core team.Maintains alignment and manages execution across all Global Quality disciplines.Collaborate with R&D, system 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.Provide leadership and guidance to create consistency in our architecture, interface, and designs that will enable platforms and future product expansion.Drive development of test strategies for complex systems, partnering with regulatory on strategies for emerging technology.Oversees the investigation and evaluation of existing technologies.Guides the conceptualization of new methodologies, materials, machines, processes or products. Ensures risk management processes are fully integrated into development processes and support production and process controls.Directs the development of new concepts from initial design to market release. Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.Manages feasibility studies of the design to determine if capable of functioning as intended.Monitors documentation maintenance throughout all phases of research and development.Regularly interacts with site leadership. Represents quality as a member of the development staff as well as serving on the quality staff.Selects, develops and evaluates personnel to ensure the efficient operation of the function.Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products.Lead external and internal regulatory audits and inspections as it pertains to design and development and sustaining.Must Have: Minimum RequirementsTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile
Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and/or engineering with 3+ years of managerial experienceORMasters Degree in Engineering or Science field with 3+ years of experience in quality and/or engineering with 3+ years of managerial experience.Nice to HaveExperience working in a regulated industry (e.g., FDA-regulated)Master’s Degree in Engineering, Quality, Regulatory, or related.Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applicationsWorking knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiativeExperience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus.Ability to author technical reports, business correspondence and standard operating procedures.Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians.Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.Self-Starter with a sharp focus on quality and customer experienceCertifications in Quality Engineering, Quality Management or Program Management.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):$136,000.00 - $204,000.00This 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.At Medtronic, most positions are posted on our career site for 3-7 days. SummaryLocation: Los Angeles, California, United States of AmericaType: Full time
