• Job Description

  Req#: R01118938

  Job Description:

  Software Quality Assurance Engineer (New Health Care Company)

  3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:

  • Proven category leadership
  • Exposure to attractive end-markets
  • Innovation mindset driving improved patient outcomes
  • Collaborative customer relationships
  • Deep global regulatory experience
  • Operational excellence and strong cash flow
  • Strong sales growth and profitability with significant recurring sales

  We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.

  This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.

  The Impact You’ll Make in this Role

  As a Software Quality Assurance Engineer you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

  • Leads software quality assurance activities throughout medical device software life cycle, including creating software quality assurance plans and cyber risk assessment plans, performing software configuration management and change control activities, facilitating threat modelling and vulnerability assessments, writing reports, performing gap assessments against applicable regulations and industry standards.
  • Implements standard operating procedures for medical device software engineering, takes an active role in continuous improvement of the medical device software engineering process, including authoring, reviewing, and approving procedures, work instructions and templates.
  • Determines software safety classification, software test readiness, software release readiness, cyber risk profile. Is expected to be an active member of the software team during the whole software life cycle, with responsibility for reviewing and approving software requirements, software design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics.
  • Oversees medical device software development, maintenance, testing, release, safety, and security risk management and ensures compliance with applicable regulatory requirements and industry standards. Immediately elevates to management any major problem with device software that could affect safety, data security, customer usability or system adherence to process requirements
  • Supports the supplier audit process, internal/external audit process and other processes as applicable, as a subject matter expert in product software providers, and perform other role related duties as assigned by management.

  Your Skills and Expertise

  To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

  • Bachelor’s degree or higher in Computer Science (completed and verified prior to start) from an accredited university
  • Three (3) years of experience in medical device software quality or other regulated industry with equivalent software safety and security standards in a private, public, government or military environment

  Additional qualifications that could help you succeed even further in this role include:

  • Working knowledge of medical device software regulations (FDA, EU and other agencies) as well as medical device related standards such as ISO 13485, ISO 14971, IEC 62304 amongst others.
  • Working knowledge of C language preferred.
  • Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams as well as ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.

  For current employees, internal transfer restrictions may not apply. For more details, contact your local recruiter/HR team.

  Work location:

  • Remote, USA

  Travel: May include up to 5% domestic

  Relocation Assistance: May be authorized

  Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

  Supporting Your Well-being

  3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

  Chat with Max

  For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.

  The expected compensation range for this position is $93,033 - $113,708, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/.

  Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M.

  Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

  Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.

  Pay & Benefits Overview: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/

  3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

  Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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• About the company

  3M applies science and innovation to make a real impact by igniting progress and inspiring innovation in lives and communities across the globe

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