Medical Devices STEM OPT Jobs in California
California's medical devices industry spans San Diego's biotech corridor, the San Francisco Bay Area, and the greater Los Angeles region, with companies like Medtronic, Boston Scientific, and Abbott employing biomedical engineers, quality engineers, and R&D specialists. Many of these employers have established F-1 STEM OPT sponsorship pathways, making California one of the most active states for medical devices OPT roles.
Find Medical Devices JobsOverview
Showing 5 of 121+ Medical Devices STEM OPT Jobs in California
See all 121+ Medical Devices STEM OPT Jobs in California
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Medical Devices STEM OPT Jobs in California.
Get Access To All JobsINTRODUCTION
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
ROLE AND RESPONSIBILITIES
The Senior Biostatistician will support clinical studies by applying statistical expertise throughout the study lifecycle, including developing and executing Statistical Analysis Plans (SAPs), performing and validating statistical analyses and programming, contributing to protocols and randomization, and supporting clinical study reports, publications, submissions, exploratory analysis for clinical and business objectives.
How you will make an impact:
- Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
- Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses.
- Review protocols and contribute to statistical analysis sections, and generate study randomization schemes when appropriate.
- Author results sections of clinical study reports and provide statistical input for PMA submissions and responses to regulatory questions.
- Provide independent validation of statistical content in study documents including randomization schemes, reports, briefing documents, patient brochures, publications, and other content delivered to external entities.
- Interpret statistical results and clearly communicate findings, assumptions, and limitations to clinical, medical, regulatory, and other cross-functional stakeholders.
- Keep abreast of new developments in statistics, clinical research, regulatory guidance and emerging statistical methodologies through literature review and attendance at workshops and professional meetings.
- Represent Biostatistics on study teams and work with management and other team members regarding study status and timeline updates.
- Independently manage statistical deliverables, priorities, and timelines for assigned studies, and proactively communicate study status, risks, and issues.
- Participate in the developing case report forms and clinical database and data support data cleaning activities to ensure high-quality data collection.
BASIC QUALIFICATIONS
- Ph.D. or equivalent in Statistics, Biostatistics, or related field, internship, senior projects, or thesis in Statistics, Biostatistics or related field.
- Master’s Degree or equivalent in Statistics, Biostatistics or related field, 2 years previous analytical experience in clinical trials.
PREFERRED QUALIFICATIONS
- Ph.D. in Epidemiology or related field, with relevant research, internships, thesis or other applied experience.
- Master’s degree in Epidemiology or related field with at least 2 years of analytical experience, preferably in clinical trials.
- Must have solid knowledge of applied statistics and regulatory requirements, as well as effective communication and collaboration skills.
- Demonstrated knowledge and experience with survival and time-to-event analysis methods.
- Strong written and verbal communication skills, including the ability to explain statistical concepts and results to both technical and non-technical stakeholders.
- Ability to work independently, take ownership of statistical deliverables, and collaborate effectively within cross-functional teams.
- Sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to pharmaceutical and medical device research settings.
- Experience with real-world data (RWD) or real-world evidence (RWE).
- Knowledge or applied experience in Bayesian statistical methods.
- Knowledge or applied experience in causal inference methods.
- Experience with machine learning, data science, or other emerging quantitative methods.
COMPENSATION
- For California, the base pay range for this position is $119,000 - $168,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
INTRODUCTION
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
ROLE AND RESPONSIBILITIES
The Senior Biostatistician will support clinical studies by applying statistical expertise throughout the study lifecycle, including developing and executing Statistical Analysis Plans (SAPs), performing and validating statistical analyses and programming, contributing to protocols and randomization, and supporting clinical study reports, publications, submissions, exploratory analysis for clinical and business objectives.
How you will make an impact:
- Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
- Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses.
- Review protocols and contribute to statistical analysis sections, and generate study randomization schemes when appropriate.
- Author results sections of clinical study reports and provide statistical input for PMA submissions and responses to regulatory questions.
- Provide independent validation of statistical content in study documents including randomization schemes, reports, briefing documents, patient brochures, publications, and other content delivered to external entities.
- Interpret statistical results and clearly communicate findings, assumptions, and limitations to clinical, medical, regulatory, and other cross-functional stakeholders.
- Keep abreast of new developments in statistics, clinical research, regulatory guidance and emerging statistical methodologies through literature review and attendance at workshops and professional meetings.
- Represent Biostatistics on study teams and work with management and other team members regarding study status and timeline updates.
- Independently manage statistical deliverables, priorities, and timelines for assigned studies, and proactively communicate study status, risks, and issues.
- Participate in the developing case report forms and clinical database and data support data cleaning activities to ensure high-quality data collection.
BASIC QUALIFICATIONS
- Ph.D. or equivalent in Statistics, Biostatistics, or related field, internship, senior projects, or thesis in Statistics, Biostatistics or related field.
- Master’s Degree or equivalent in Statistics, Biostatistics or related field, 2 years previous analytical experience in clinical trials.
PREFERRED QUALIFICATIONS
- Ph.D. in Epidemiology or related field, with relevant research, internships, thesis or other applied experience.
- Master’s degree in Epidemiology or related field with at least 2 years of analytical experience, preferably in clinical trials.
- Must have solid knowledge of applied statistics and regulatory requirements, as well as effective communication and collaboration skills.
- Demonstrated knowledge and experience with survival and time-to-event analysis methods.
- Strong written and verbal communication skills, including the ability to explain statistical concepts and results to both technical and non-technical stakeholders.
- Ability to work independently, take ownership of statistical deliverables, and collaborate effectively within cross-functional teams.
- Sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to pharmaceutical and medical device research settings.
- Experience with real-world data (RWD) or real-world evidence (RWE).
- Knowledge or applied experience in Bayesian statistical methods.
- Knowledge or applied experience in causal inference methods.
- Experience with machine learning, data science, or other emerging quantitative methods.
COMPENSATION
- For California, the base pay range for this position is $119,000 - $168,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
STEM OPT Medical Devices Job Roles in California
See all 121+ Medical Devices STEM OPT Jobs in California
Sign up for free to filter by visa type, set job alerts, and find employers with verified sponsorship history.
Search Medical Devices Jobs in CaliforniaMedical Devices STEM OPT Sponsorship Jobs in California: Frequently Asked Questions
Which medical devices companies sponsor F-1 STEM OPT visas in California?
California-based and California-operating medical devices companies with documented STEM OPT sponsorship history include Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, Becton Dickinson, and Intuitive Surgical. Smaller contract manufacturers and digital health startups in the San Diego and Bay Area corridors also sponsor OPT students, particularly for engineering and quality roles. Sponsorship patterns vary by company size, hiring cycle, and the specific role's STEM degree classification eligibility.
Which cities in California have the most medical devices F-1 STEM OPT sponsorship jobs?
San Diego leads California for medical devices OPT hiring, driven by a dense cluster of device manufacturers and contract research organizations in the Sorrento Valley and Torrey Pines areas. The San Francisco Bay Area, particularly Sunnyvale and Santa Clara, hosts strong robotics and digital health device employers. Los Angeles and Orange County round out the state's major hiring hubs, especially for combination products and orthopedic device companies.
What types of medical devices roles typically qualify for F-1 STEM OPT sponsorship?
Roles that most commonly qualify include biomedical engineering, electrical engineering, mechanical engineering, software engineering for embedded or regulatory systems, quality assurance engineering, regulatory affairs, and manufacturing process engineering. These positions typically map to STEM-designated STEM degree classifications, which is a requirement for STEM OPT extension eligibility. Always verify that the specific job title and STEM degree classification assigned by your employer appear on the official STEM OPT designated degree list.
How do I find medical devices F-1 STEM OPT sponsorship jobs in California?
Migrate Mate filters job listings specifically by visa type and industry, so you can search directly for medical devices roles in California that have F-1 STEM OPT sponsorship. This removes the guesswork of contacting employers who don't sponsor. You can also cross-reference employer LCA filing history through OFLC to confirm which California medical devices companies have an active sponsorship track record before applying.
Are there any California-specific considerations for F-1 STEM OPT sponsorship in medical devices?
California's stringent labor laws and its status as an at-will employment state do not directly affect OPT eligibility, but they do shape how employers structure internships versus full-time roles. Medical devices companies in California operating under FDA 21 CFR Part 820 quality regulations often require OPT hires to participate in formal training programs, which must align with the student's degree field to satisfy STEM OPT's requirement that the position be related to the qualifying STEM degree.