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Biomedical Engineer
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Koya Medical
Remote
Full-Time
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Job Description
Biomedical Engineer - Medical Device Development (Catheter Systems)
Key ResponsibilitiesLead design and development of catheter-based medical devices, including RF, microwave, cryo, and thermal ablation catheter systems.
Create and iterate CAD models and detailed part drawings using SolidWorks to support prototyping and transition to manufacturing.
Build and manage rapid prototypes and functional assemblies; plan and execute engineering tests, bench evaluations, and design verification studies.
Develop and maintain Design History File (DHF) documentation, design control records, and technical documentation required for regulatory submissions.
Support preparation of regulatory submission materials and liaise with regulatory/quality teams to ensure compliance with FDA requirements and international standards.
Implement and maintain risk management activities in accordance with ISO 14971, including creation and update of risk analyses and mitigation plans.
Coordinate GLP preclinical studies and provide engineering support for early clinical trials, including test protocols, data collection, and troubleshooting.
Work with suppliers and contract manufacturers to qualify components, manage change control, and ensure supply chain robustness.
Collaborate cross-functionally with electrical, mechanical, clinical, and quality teams to resolve technical issues and drive product development milestones.
Support sterilization and biocompatibility strategy (ISO 10993) and sterilization validation processes (e.g., ISO 11135) as they relate to device materials and manufacturing.
QualificationsBachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, or related field.3+ years of experience in medical device development, preferably with catheter systems or interventional devices; experience with RF/microwave/cryo/thermal ablation technologies is strongly preferred.
Proven proficiency in CAD (SolidWorks) and hands-on prototyping and engineering testing.
Direct experience preparing and maintaining DHF documentation, design controls, and technical files for regulatory submissions.
Solid working knowledge of
Experience supporting GLP preclinical studies and early clinical trials, including familiarity with study protocols and data management expectations.
Familiarity with biocompatibility testing requirements (ISO 10993) and sterilization standards and methods (ISO 11135 preferred).Experience with supplier management, component qualification, and design transfer to manufacturing.
Strong analytical and problem-solving skills, excellent written and verbal communication, and ability to work effectively in multidisciplinary teams.
Location:
Hybrid (Tue-Thurs) in OaklandPosition OverviewWe are seeking a Biomedical Engineer to support design, development, and regulatory readiness for novel medical devices, with a focus on thermal ablation catheter systems. This role will drive R D activities from concept through prototyping, verification and validation, and support GLP preclinical studies and early clinical trials. The successful candidate will balance hands-on engineering (CAD/prototyping/testing) with documentation and regulatory coordination to ensure safe, compliant, and manufacturable products.Key ResponsibilitiesLead design and development of catheter-based medical devices, including RF, microwave, cryo, and thermal ablation catheter systems.
Create and iterate CAD models and detailed part drawings using SolidWorks to support prototyping and transition to manufacturing.
Build and manage rapid prototypes and functional assemblies; plan and execute engineering tests, bench evaluations, and design verification studies.
Develop and maintain Design History File (DHF) documentation, design control records, and technical documentation required for regulatory submissions.
Support preparation of regulatory submission materials and liaise with regulatory/quality teams to ensure compliance with FDA requirements and international standards.
Implement and maintain risk management activities in accordance with ISO 14971, including creation and update of risk analyses and mitigation plans.
Coordinate GLP preclinical studies and provide engineering support for early clinical trials, including test protocols, data collection, and troubleshooting.
Work with suppliers and contract manufacturers to qualify components, manage change control, and ensure supply chain robustness.
Collaborate cross-functionally with electrical, mechanical, clinical, and quality teams to resolve technical issues and drive product development milestones.
Support sterilization and biocompatibility strategy (ISO 10993) and sterilization validation processes (e.g., ISO 11135) as they relate to device materials and manufacturing.
QualificationsBachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, or related field.3+ years of experience in medical device development, preferably with catheter systems or interventional devices; experience with RF/microwave/cryo/thermal ablation technologies is strongly preferred.
Proven proficiency in CAD (SolidWorks) and hands-on prototyping and engineering testing.
Direct experience preparing and maintaining DHF documentation, design controls, and technical files for regulatory submissions.
Solid working knowledge of
FDA 21 CFR 820
(QSR), ISO 13485, andISO 14971
requirements.Experience supporting GLP preclinical studies and early clinical trials, including familiarity with study protocols and data management expectations.
Familiarity with biocompatibility testing requirements (ISO 10993) and sterilization standards and methods (ISO 11135 preferred).Experience with supplier management, component qualification, and design transfer to manufacturing.
Strong analytical and problem-solving skills, excellent written and verbal communication, and ability to work effectively in multidisciplinary teams.