Description
Design, develop, and evaluate medical devices, diagnostics, prosthetics, and clinical systems by applying engineering, biology, chemistry, computer science, and biomechanics. Collaborate with clinicians to ensure safety, efficacy, usability, and regulatory compliance across the product lifecycle from concept and modeling through verification, validation, and deployment in healthcare settings.
- • Evaluate the safety, performance, and reliability of biomedical devices and instrumentation.
- • Advise clinicians and hospital administrators on selection, deployment, and lifecycle management of medical equipment.
- • Research and test biomaterials for implants, prosthetics, and tissue-contacting devices.
- • Build and validate computational models or simulations of human physiological systems.
- • Collaborate with physicians, life scientists, and chemists on device design and clinical requirements.
- • Design hardware and software for medical applications, including embedded and data systems.
- • Analyze new clinical procedures and device uses to forecast risks and outcomes.
- • Train clinicians and technicians on proper operation, maintenance, and safety of equipment.
- • Author protocols, user manuals, and maintenance and repair procedures for medical devices.
- • Support design for manufacturability and packaging of devices with manufacturing teams.
- • Work with quality and manufacturing teams to develop specifications, SOPs, and validation reports.
- • Prepare and support regulatory submissions and compliance with standards and guidance.
- • Coordinate with suppliers on component selection, specifications, and qualification.
- • Align design intent with production capabilities through design transfer activities.
- • Design, test, and deliver assistive technologies and prosthetic solutions.
- • Plan and execute experiments to characterize device performance and meet design objectives.
- • Develop diagnostic and clinical instrumentation using engineering and human factors principles.
- • Conduct prototype builds, bench tests, and process validations to optimize reliability, cost, and yield.
- • Develop sterilization, biocompatibility, and packaging validation strategies for devices.
- • Create methodologies and documentation to transfer designs from R&D to commercial production.
- • Develop statistical models, analyses, or simulations to support design decisions and risk assessments.
- • Lead continuous improvement studies of clinical workflows or production test protocols.
- • Maintain databases and traceability of design inputs, test results, and nonconformances.
- • Manage engineering project schedules, budgets, resources, and vendors.
- • Prepare technical reports, publications, and patent or regulatory documentation.
- • Review literature and standards to track advances in biomedical engineering and regulations.
- • Recommend materials, components, and specifications based on test and simulation results.
- • Perform risk management, including hazard analysis, FMEA, and mitigation plans.
- • Conduct verification, validation, and usability studies to demonstrate safety and effectiveness.
- • Investigate device failures and implement corrective and preventive actions.
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Advanced Manufacturing
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
