Katalyst Healthcares and Life Sciences
Senior R&D Engineer
Katalyst Healthcares and Life Sciences, San Francisco, California, United States, 94199
Responsibilities:
Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. Requirements:
Bachelor's or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.
Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. Requirements:
Bachelor's or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.