Hardware Engineer 2

Dexcom; San Diego (CA); On-site; USD 91,000 - 152,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Career development programs

Innovative culture

Job summary

Dexcom Inc. is seeking a Postmarket Investigations professional focused on ensuring patient safety and product reliability through rigorous postmarket surveillance and CAPA support.

You will collaborate with Regulatory Affairs, Quality Assurance, R&D, and Clinical teams to investigate software- and device-related issues and drive data-driven improvements. The role emphasizes applying structured problem-solving, root-cause analyses, and risk assessments to deliver actionable recommendations that

Qualifications

• > Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years related experience or Master's degree and 0-2 years' equivalent experience.
• > Experience supporting hardware quality and reliability activities across the product lifecycle.
• > Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and global regulations.

Responsibilities

• > Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues.
• > Lead development and improvement of complaint investigations and risk assessments.
• > Evaluate hardware product performance and identify opportunities for improvement.
• > Apply structured problem-solving and data-driven approaches to investigations.
• > Communicate outcomes to technical and non-technical stakeholders.
• > Support CAPA, HHEs, and other quality system activities.
• > Conduct hardware-focused risk assessments related to anomalies and regulatory compliance.
• > Translate postmarket insights into actionable product improvements.

Skills

Quality systems

Regulatory knowledge

Postmarket surveillance

CAPA

Root cause analysis

Statistical analysis

Cross-functional collaboration

Hardware risk management

Communication skills

Problem solving

Education

Bachelor's degree in technical discipline

Master's degree (preferred)

Tools

DFMEA

PFMEA

Statistical software

Reliability testing

Job description

Meet the team:

At Dexcom, the Postmarket Investigations team serves as a critical link between real-world product performance and continuous product improvement. As part of the Customer Advocacy organization, we assess postmarket feedback and product data to ensure learnings are integrated into future product enhancements. This role has a direct impact on patient safety, product reliability, and regulatory compliance through partnership with teams across R&D, Quality, and Commercial Operations. Our team values technical excellence, accountability, and continuous learning, while fostering a collaborative and supportive environment. Team members have the unique opportunity to drive quality improvements, influence key business processes, and contribute to technologies that empower people to take control of their health.

Where you come in

• You will collaborate with cross-functional partners including Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to support the investigation, documentation, and resolution of software- and device-related postmarket issues.
• You will drive the development and continuous improvement of complaint investigation processes, ensuring alignment with software risk management activities such as hazard analysis, DFMEA, PFMEA, and product risk assessments.
• You will develop and maintain a deep understanding of Dexcom’s hardware ecosystem to effectively evaluate product performance, investigate anomalies, and identify opportunities for continuous improvement.
• You will apply structured problem-solving methodologies and data-driven approaches to conduct investigations, lead engineering studies, and identify root causes using statistical analysis and industry-standard tools.
• You will analyze, synthesize, and communicate investigation outcomes to technical and non-technical stakeholders, providing clear recommendations and supporting informed decision-making across the organization.
• You will contribute to postmarket quality processes, including CAPA, Health Hazard Evaluations (HHEs), and other quality system activities, ensuring thorough assessment of product performance and risk.
• You will perform hardware-focused risk assessments related to product anomalies, clinical impact, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory compliance.
• You will partner with product development and quality teams to translate postmarket insights into actionable improvements, driving enhancements to product performance, user experience, and patient safety.

What makes you successful

• You have demonstrated knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and other applicable global regulations, with a strong understanding of postmarket surveillance, complaint handling, CAPA, and vigilance reporting requirements.
• You have experience supporting hardware quality and reliability activities throughout the product lifecycle, including design and development, verification and validation, field performance monitoring, and postmarket surveillance.
• You have strong understanding of hardware risk management principles and methodologies, with the ability to evaluate and mitigate product risks, assess field safety signals, and apply risk-based decision-making in alignment with regulatory expectations and industry best practices.
• You have excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization.
• You have working knowledge of hardware engineering principles and technologies, including electromechanical systems, electronics, sensors, materials, reliability engineering, manufacturing processes, and failure analysis techniques used in medical device development and support.
• You have proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions.
• You have strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations.
• You have the ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience.
• You have experience performing postmarket surveillance activities, including complaint investigations, trending and signal detection, reliability analysis, risk assessments, CAPA support, periodic product reviews, and communication of field performance insights to internal and external stakeholders.

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

• 0-5%

Experience and Education Requirements

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

Flex Workplace

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

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

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

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

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

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

$91,400.00 - $152,300.00