About Dexcom
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class – while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
Meet the team:
As a Senior Safety Engineer at Dexcom, you will play a crucial role in ensuring the safety and reliability of our cutting-edge medical devices and technologies. Dexcom is a leader in continuous glucose monitoring systems, empowering people to take control of health. In this role, you will be responsible for designing and implementing comprehensive safety programs to mitigate risks and enhance the safety performance of our products.
Where you come in:
- You will lead and drive safety-related initiatives throughout the product development lifecycle, from concept to post-market surveillance.
- You will collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to integrate safety requirements into product designs and manufacturing processes.
- You will conduct thorough risk assessments and hazard analyses to identify potential safety issues and develop effective risk mitigation strategies.
- You will review and analyze safety data, complaints, and adverse events to assess product performance and identify areas for improvement.
- You will review equipment design to ensure equipment and tooling adheres to ANSI, ISO, RIA, EN, NFPA, GB and OSHA equipment, machinery, and electrical safety standards components that could be affected by new equipment or changes in current equipment.
- You will perform factory acceptance testing (FAT) to ensure manufacturers have incorporated applicable ANSI and OSHA standards into the equipment and perform (SAT) site acceptance testing, to ensure equipment is safe for operation.
- You will participate in design reviews and ensure compliance with relevant safety standards and regulations.
- You will develop and maintain safety-related documentation, including risk management files and safety reports, to meet regulatory requirements.
- You will contribute to the development and improvement of safety-related processes and procedures.
- You will stay up-to-date with industry trends, best practices, and regulatory changes related to medical device safety.
What makes you successful:
- You must have proven experience (typically 5+ years) in medical device safety engineering, preferably in the healthcare industry or similar regulated environments.
- You must have strong knowledge of relevant safety standards and regulations (e.g., ISO 14971, IEC 60601, FDA guidelines) and experience with reviewing equipment design to ensure equipment and tooling adheres to ANSI, ISO, RIA, EN, NFPA, GB and OSHA equipment, machinery, and electrical safety standards components.
- You must have experience with risk management methodologies, such as FMEA and fault tree analysis.
- You must have excellent analytical and problem-solving skills, with a keen eye for detail and an ability to work effectively in a collaborative team environment, communicating complex safety concepts to cross-functional stakeholders and demonstrated project management skills, capable of handling multiple tasks and priorities simultaneously.
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%
Exempt Salary Details:
The annual base salary range for this role is $87,000 to $145,000 Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.
Experience and Education
- Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters 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 talentacquisition@dexcom.com.
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 talentacquisition@dexcom.com.
View the OFCCP’s Pay Transparency Non Discrimination Provision at this link.
UnitedHealthcare 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://transparency-in-coverage.uhc.com/.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.