Sr SW Design Quality Engineer

Regulatory Toolkit; San Diego (CA); On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Benefits program

Growth opportunities

Tuition reimbursement

Job summary

Dexcom Corporation is seeking a Senior Software Design Assurance Engineer to provide technical support and guidance to software teams for conformance to safety and quality standards (IEC 62304, ISO 13485, ISO 14971). This role interfaces with cross-functional groups and emphasizes defect prevention, product improvement, and compliance across software development and validation.

Responsibilities include leading risk management deliverables, guiding software design and test teams, and reviewing

Qualifications

• Medical Device experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Experience with SDLC processes and methodologies such as Agile and Waterfall
• Software Quality/Engineering across requirements, design, integration and test
• Ability to interpret software design and code to verify requirements
• Experience with cloud-based systems

Responsibilities

• Actively participates as a core member of the R&D Quality Assurance Engineering team
• Provide guidance on IEC 62304, 21 CFR 820, and global regulations
• Lead application and continuous improvement of processes for software development and validation
• Drive pre-market risk management deliverables and support cyber security risk management
• Review and approve software design control deliverables and support post-market activities

Skills

IEC 62304

FDA 21 CFR 820

SDLC

Agile / Waterfall

Cloud-based systems

Education

Bachelor’s degree in a technical discipline

Master’s degree in related field

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the Team:

*This is not a test role*

TheSeniorSoftware Design Assurance (SrSoftware Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g.IEC 62304, ISO 13485, ISO 14971). This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention. This position will interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

*This is not a test role*

Where you come in:

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
• Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management
• Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
• Reviews and approves all software design control deliverables
• Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
• Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
• Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
• Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.
• Assumes and performs other duties as assigned.

What makes you successful:

• Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Ability to interpret software design and code to verify implementation of requirements
• Software development and/or Software test experience
• Ability to communicate and present to all levels of management.
• Ability to understand complex tasks and goals. Drive projects to completion with limited supervision.
• Experience working with cloud-based systems.

Preferred Requirements:

• ASQ Certified Software Quality Engineer (CSQE)
• Cyber Security experience
• Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously.

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Experience and Education Requirements:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

Salary: $95,900.00 - $159,900.00