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Engineering Manager - Software Design Quality

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Medtronic

1mo ago

  • Job
    Full-time
    Senior Level
  • Engineering
  • San Diego, +1
  • Quick Apply

AI generated summary

  • You need a relevant bachelor's or advanced degree, 5+ years in Digital/Cloud, 5 years in leadership, and experience in regulated industries. Familiarity with ISO standards is a plus.
  • You will lead a design quality team, ensure compliance with regulations, manage software reliability, guide cross-functional collaboration, and drive continuous improvement in processes and personnel.

Requirements

  • Must Have: Minimum Requirements:
  • To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
  • Bachelor’s degree required in Engineering, Science or technical field with 5+ years of experience in the Digital and Cloud space and 5 years of technical leadership or managerial experience.
  • OR, Advanced Degree in Engineering, Science or 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.

Responsibilities

  • Medtronic leads the health care 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 include 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 be asked to manage and guide the design quality engineers in the pre-market design and sustaining space. You will be responsible to drive development of safe, reliable, and compliant products/systems while working very closely with the cross functional teams and building a highly technical and competitive design quality engineers.
  • The best candidates will be critical thinkers, problem solvers, strong executers, self-driven with strong leadership skills & hands-on management approach. Strong relationship skills are a must, as is excellent verbal and written communication. 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.
  • Manages activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance.
  • Provides 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.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Communicate program status using clear metrics and specific actions plans, applying organizational acumen appropriate for a senior level audience.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Working knowledge of IEC 62304, 21 CFR 820.30 and ISO 14971
  • Manages feasibility studies of the design to determine if capable of functioning as intended.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

FAQs

What is the main responsibility of the Engineering Manager - Software Design Quality at Medtronic?

The main responsibility is to lead the Software Design Quality team focused on Medtronic’s Digital portfolio, managing and guiding design quality engineers in both pre-market design and sustaining phases, ensuring the development of safe, reliable, and compliant medical device products and systems.

What qualifications are required for this position?

A Bachelor’s degree in Engineering, Science, or a technical field with 5+ years of experience in the Digital and Cloud space, including 5 years of technical leadership or managerial experience is required. Alternatively, an Advanced Degree with 3+ years of relevant experience may also be considered.

What specific software and regulatory knowledge is preferred for this role?

Candidates are preferred to have a working knowledge of IEC 62304, 21 CFR 820.30, ISO 14971, ISO 13485, and IEC 60601-1, along with experience in regulated industries like medical devices, healthcare or aerospace.

What are some key skills and traits that the ideal candidate should possess?

The ideal candidate should be a critical thinker, problem solver, strong executor, self-driven with excellent leadership skills, hands-on management, and strong relationship skills, complemented by excellent verbal and written communication abilities.

How does the Engineering Manager communicate program status?

The Engineering Manager communicates program status using clear metrics, specific action plans, and applies organizational acumen appropriate for a senior-level audience.

Is experience in software or systems engineering important for this job?

Yes, direct experience in software or systems engineering in a design engineering role is considered a valuable asset for this position.

What does the compensation package include?

The compensation package includes a competitive salary, a flexible benefits package, and eligibility for a short-term incentive called the Medtronic Incentive Plan (MIP). Salary ranges for this role in the U.S. are between $136,000.00 - $204,000.00, depending on experience, education, market conditions, and location.

How does Medtronic support career and life stages for its employees?

Medtronic offers a wide range of benefits, resources, and competitive compensation plans designed to support employees throughout their career and life stages, and values their contributions to the company's success.

What is the work environment like for this position?

The work environment may include both office-based settings and potential interactions with team members, requiring independent mobility and communication abilities, particularly while interacting with computers and peers.

What is the mission of Medtronic?

Medtronic's mission is to alleviate pain, restore health, and extend life, uniting a global team of passionate individuals in tackling the most challenging health problems facing humanity and seeking innovative solutions.

Medtronic

Engineering the extraordinary

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Medtronic is a global medical technology company that designs, manufactures, and markets a wide range of medical devices and therapies. The company's products and solutions cover a broad spectrum of healthcare areas, including cardiac and vascular therapies, diabetes management, neurological and spinal treatments, surgical technologies, and more. Medtronic's ultimate mission is to improve the lives of patients around the world by advancing medical innovation, providing life-saving and life-enhancing solutions, and transforming the way healthcare is delivered. Their purpose is to alleviate pain, restore health, and extend the lives of patients through cutting-edge medical technologies, personalised therapies, and continuous research and development. With a commitment to delivering quality and affordable healthcare solutions, Medtronic seeks to make a positive impact on patients, healthcare professionals, and healthcare systems worldwide.