Medtronic
Manager, SW Design Quality -Digital Products
Medtronic, Los Angeles, California, United States, 90079
We anticipate the application window for this opening will close on - 21 Feb 2025.
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 Life Medtronic leads the healthcare industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through our rich software system, which includes mobile and cloud-based applications combined with scaled infrastructure and advanced analytics. Become part of our team, and you will be challenged to build these amazing software products and, in the process, make a real difference.
As a Software Design Quality Manager, you will lead the Software Design Quality team focused on Medtronic’s Digital portfolio (Mobile Apps, Cloud, etc.). You will manage and guide the design quality engineers in the pre-market design and sustaining space. You will be responsible for driving the development of safe, reliable, and compliant products/systems while working closely with cross-functional teams and building a highly technical and competitive design quality engineering team.
The best candidates will be critical thinkers, problem solvers, strong executors, self-driven with strong leadership skills, and a hands-on management approach. Strong relationship skills are a must, as is excellent verbal and written communication.
This position is located in Northridge, CA or San Diego, CA (hybrid).
Responsibilities may include the following and other duties may be assigned:
Plans, directs, and implements all quality aspects of the company's design and development of new and sustaining medical device products
or software systems, with detailed focus on software reliability, risk management, and patient safety. Provide oversight and training in the application of work processes to ensure successful adoption by development teams and positive, measurable results obtained from development programs. Work closely with cross-functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities. Manage activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance. Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures
that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Ensure the quality assurance programs and policies are maintained and modified regularly. Communicate program status using clear metrics and specific action plans, applying organizational acumen appropriate for a senior-level audience. Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. Working knowledge of IEC 62304, 21 CFR 820.30, and ISO 14971. Manage feasibility studies of the design to determine if capable of functioning as intended. Select, develop, and evaluate personnel to ensure the efficient operation of the function. Must Have: Minimum Requirements Bachelor’s degree required in Engineering, Science, or a technical field with 5+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience. OR, an Advanced Degree in Engineering, Science, or a technical field with 3+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience. Nice to Have: Direct experience in software or systems engineering in a design engineering role. Extensive experience in complex product development projects with strong knowledge of product development in regulated industries (such as medical device, healthcare, aerospace, or transportation industries). Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, and MDD/EU MDR. Ability to author technical reports, business correspondence, and standard operating procedures. Experience in applying metrics to measure and improve processes and product quality during product development. Proven track record of success in leading cross-functional efforts in work process improvement. Experience in influencing, educating, and fostering others in adopting work practices. Strong employment history of assuming successive organizational roles with increasing responsibility. Physical Job Requirements The 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 & Compensation
Medtronic offers a competitive salary and flexible benefits package.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. A commitment to our employees' lives is 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 - $204,000.00. This 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). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental, and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We 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. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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or software systems, with detailed focus on software reliability, risk management, and patient safety. Provide oversight and training in the application of work processes to ensure successful adoption by development teams and positive, measurable results obtained from development programs. Work closely with cross-functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities. Manage activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance. Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures
that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Ensure the quality assurance programs and policies are maintained and modified regularly. Communicate program status using clear metrics and specific action plans, applying organizational acumen appropriate for a senior-level audience. Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. Working knowledge of IEC 62304, 21 CFR 820.30, and ISO 14971. Manage feasibility studies of the design to determine if capable of functioning as intended. Select, develop, and evaluate personnel to ensure the efficient operation of the function. Must Have: Minimum Requirements Bachelor’s degree required in Engineering, Science, or a technical field with 5+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience. OR, an Advanced Degree in Engineering, Science, or a technical field with 3+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience. Nice to Have: Direct experience in software or systems engineering in a design engineering role. Extensive experience in complex product development projects with strong knowledge of product development in regulated industries (such as medical device, healthcare, aerospace, or transportation industries). Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, and MDD/EU MDR. Ability to author technical reports, business correspondence, and standard operating procedures. Experience in applying metrics to measure and improve processes and product quality during product development. Proven track record of success in leading cross-functional efforts in work process improvement. Experience in influencing, educating, and fostering others in adopting work practices. Strong employment history of assuming successive organizational roles with increasing responsibility. Physical Job Requirements The 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 & Compensation
Medtronic offers a competitive salary and flexible benefits package.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. A commitment to our employees' lives is 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 - $204,000.00. This 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). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental, and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We 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. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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