Sr SW Design Quality Engineer
Dexcom · San Diego, CA
- Level
- Senior
- Team
- Quality
- Base pay
- $96k–$160k
- Degree
- Required
- Experience asked
- 25+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
A senior quality role at Dexcom (medical devices) in San Diego, CA.
- They ask for
- 25+ years · degree required
- Tools it names
- FMEA, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)
- Base pay
- $96k–$160k
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
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
- ✓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.
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.
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 a
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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 *
The Senior Software Design Assurance ( Sr 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
- •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
Analysis, Design/Development, Product Integration and Test
- •Ability to interpret software design and code to verify implementation of
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.