Software Design QA Engineer 2

RXinsider LTD.; San Diego (CA); Hybrid; USD 79,000 - 132,000; Full time

Benefits offered by this job

Comprehensive benefits program

Growth opportunities

Tuition reimbursement

Career development

Job summary

Dexcom Corporation seeks a Software Design Assurance Engineer to ensure conformance to software development processes and global safety standards. You will collaborate with Software Engineering, Regulatory, Marketing, and Cybersecurity to improve product quality and safety.

You will drive pre-market risk management, review design history files, support validation, and communicate status to leadership in a fast-paced environment. FDA 21 CFR Part 820 and SDLC knowledge are required.

Qualifications

• You have Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
• Knowledge of SDLC processes and methodologies (Agile, Waterfall, etc.).
• Experience in Software Quality or Engineering: Requirements Analysis, Design/Development, Product Integration and Test.

Responsibilities

• Act as core team member of the R&D Quality Assurance Engineering team.
• Guide on IEC 62304, 21 CFR 820, and global regulatory standards.
• Drive pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management.
• Review and approve all software design control deliverables.
• Support post-market activities related to software anomalies, risk assessments and CAPA.
• Lead and support R&D SW Design Assurance efforts including continuous improvement.
• Review, author, and revise design history files, SOPs, protocols and reports.

Skills

Medical Device Compliance

SDLC / Methodologies

Software Quality / Engineering

Requirements Analysis

Design / Development / Test

Cloud-based Systems

Communication & Presentation

Education

Bachelor's degree in a technical discipline

Master's degree (optional)

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

The Software Design Assurance (Software 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

• You will actively participates as a core team member of the R&D Quality Assurance Engineering team.
• You have an understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
• You will drive pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management
• You will provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
• You will review and approve all software design control deliverables
• You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
• You will lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes
• You will be responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
• You will assess the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
• You will effectively communicate with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.

What Makes You Successful

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

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.

Travel Required

5-15%

Education And Experience

Typically requires a Bachelor's degree in a technical discipline and 2–5 years of related experience, or a Master's degree and 0–2 years of equivalent industry experience.

Remote Workplace

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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].

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary

$78,900.00 - $131,500.00