Medical Devices STEM OPT Jobs in Colorado
Medical devices F-1 STEM OPT sponsorship jobs in Colorado are concentrated in the Denver metro and Boulder corridor, where companies like DaVita, Medtronic, and Smith+Nephew maintain engineering and regulatory affairs operations. Colorado's growing life sciences sector creates consistent demand for biomedical engineers, quality assurance specialists, and device development roles that qualify for STEM OPT authorization.
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Job description
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Stryker’s Sports Medicine division is hiring a Staff Biocompatibility Scientist to provide technical expertise in biocompatibility, biological safety, and medical device microbiology across new product development and sustaining projects. This role leads biological evaluations, risk assessments, and testing strategies for complex medical devices, while supporting sterilization, device cleanliness, bacterial endotoxin, and reusable device processing. The successful candidate will apply expertise in ISO 10993-1:2025, quality systems, and design controls while partnering cross-functionally to support patient safety and global regulatory submissions.
Workplace Flexibility: This is a hybrid role requiring the candidate to be within commuting distance to Greenwood Village, CO. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to the facility as needed.
What you will do
- Independently develop, author, and maintain biological evaluation strategies, plans, reports and risk assessments for implantable, non-implantable, single-use, and reusable medical devices in accordance with ISO 10993-1:2025 and ISO 14971
- Apply ISO 10993-1:2025 to identify biological hazards, estimate and evaluate biological risks, establish risk controls, and assess residual risk throughout the medical device lifecycle
- Critically evaluate material and process information chemical characterization, toxicological risk assessments, literature, and biological test data to identify evidence gaps, determine testing needs, and document scientifically justified conclusions
- Assess product, material, supplier, manufacturing, cleaning, packaging, sterilization and lifecycle changes for biological safety and microbiological impact, including biological equivalence and required validation activities
- Independently plan and execute assigned microbiology activities, including test plans, sampling strategies, acceptance criteria, and evaluation of bioburden, sterility, bacterial endotoxin, ethylene oxide/ethylene chlorohydrin residuals, and contamination control data
- Develop and evaluate cleaning, disinfection, and sterilization validation strategies for assigned devices, including the effects of repeated processing on device cleanliness and biological safety
- Coordinate external laboratory studies, defining study scope, test article selection, protocol review, resolving technical issues, and critically evaluating final reports
- Monitor applicable standards and regulatory guidance, perform gap and product-impact assessments, implement approved documentation updates, and prepare technical responses to regulatory authorities and notified bodies in partnership with Regulatory Affairs
What you need
Required Qualifications:
- Bachelor’s degree in microbiology, biology, chemistry, toxicology, biomedical engineering, or a closely related scientific discipline
- Minimum of 4 years of relevant experience, including at least 2 years independently leading technical biocompatibility projects in the medical device industry.
- Demonstrated experience applying ISO 10993-1:2025 and applicable ISO 10993 standards to biological evaluations, risk assessments, test strategies, and technical reports.
- Experience evaluating material and process information, chemical characterization, toxicological risk assessments, scientific literature, and biological test data to support biological safety conclusions.
- Experience assessing the impact of sterilization, manufacturing cleanliness, EO residuals, and/or reusable device processing on medical device biological safety.
- Experience working within medical device quality systems, including design controls and change control, to support technical assessments and documentation.
Preferred Experience:
- Experience supporting FDA submissions, EU MDR technical documentation, notified body reviews, or other global regulatory submissions
- Experience participating in regulatory inspections or supplier audits involving cleanroom or sterilization processes.
Posted Date: 10/28/2026
This role will be posted for a minimum of 3 days.
Compensation
- Salary Range: $91,600 - $152,700 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
STEM OPT Medical Devices Job Roles in Colorado
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Search Medical Devices Jobs in ColoradoMedical Devices STEM OPT Sponsorship Jobs in Colorado: Frequently Asked Questions
Which medical devices companies sponsor F-1 STEM OPT visas in Colorado?
Colorado-based medical devices employers with documented OPT hiring patterns include Medtronic's Broomfield operations, DaVita (medical technology division), Smith+Nephew in Denver, and Spectra Logic. Smaller contract manufacturers and Class II device startups in the Boulder and Colorado Springs corridors also participate, particularly for biomedical engineering and regulatory affairs roles. Reviewing DOL Labor Condition Application disclosure data helps confirm which specific employers have sponsored STEM-adjacent positions.
Which cities in Colorado have the most medical devices F-1 STEM OPT sponsorship jobs?
Denver and its northern suburbs, including Broomfield, Westminster, and Lakewood, concentrate the largest share of Colorado medical devices sponsorship activity. Boulder supports a cluster of diagnostics and healthtech firms tied to the University of Colorado ecosystem. Colorado Springs has emerging device manufacturing presence. Golden and Fort Collins host smaller but active biomedical engineering employers connected to Colorado School of Mines and Colorado State University research programs.
What types of medical devices roles typically qualify for F-1 STEM OPT sponsorship?
Roles that commonly qualify combine a STEM-designated degree with direct application to device development or quality systems. These include biomedical engineer, quality assurance engineer, regulatory affairs specialist, R&D engineer, manufacturing process engineer, and clinical data analyst. The position must be paid, directly related to the student's degree field, and the employer must be enrolled in E-Verify, a federal requirement for all STEM OPT sponsoring employers. O*NET occupation codes help confirm degree-to-role alignment.
How do I find medical devices F-1 STEM OPT sponsorship jobs in Colorado?
Migrate Mate filters medical devices jobs in Colorado specifically by F-1 STEM OPT eligibility, surfacing employers with verified E-Verify enrollment and LCA filing history in life sciences. This removes the manual step of cross-referencing DOL disclosure data yourself. Search by city or company to narrow results to Denver, Boulder, or Colorado Springs employers actively posting device engineering and regulatory roles that align with STEM OPT authorization requirements.
Are there any Colorado-specific considerations for F-1 STEM OPT in medical devices?
Colorado does not impose state-level restrictions on OPT employment, but medical devices roles often intersect with FDA regulatory requirements that affect hiring timelines. Employers in Class II and Class III device categories frequently require candidates to clear background checks before start dates, which can affect OPT 90-day unemployment clock management. Colorado's bioscience sector is also heavily grant-funded, so some research-adjacent positions at university-affiliated labs may not qualify if the employer lacks E-Verify enrollment.