Katalyst CRO
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Senior Quality R&D Design Engineer
role at
Katalyst CRO .
Job Description Our client is a privately held medical device company based in Northern California, rapidly developing disease‑modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. We are building a portfolio of technologies to address the needs of interventional pulmonologists, radiologists, cardiac and thoracic surgeons, and physicians treating pulmonary disease.
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.
Support updates to design control and risk documentation during design changes, sustaining engineering, or complaint investigations.
Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.
Drive continuous improvement of design control and risk management processes to enhance efficiency and compliance.
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.
Familiarity with CAD software and testing tools a plus.
Travel & Location
Onsite in Redwood City, CA with flexibility to work in a hybrid capacity.
Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Information Technology
Industries: Civil Engineering
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Senior Quality R&D Design Engineer
role at
Katalyst CRO .
Job Description Our client is a privately held medical device company based in Northern California, rapidly developing disease‑modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. We are building a portfolio of technologies to address the needs of interventional pulmonologists, radiologists, cardiac and thoracic surgeons, and physicians treating pulmonary disease.
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.
Support updates to design control and risk documentation during design changes, sustaining engineering, or complaint investigations.
Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.
Drive continuous improvement of design control and risk management processes to enhance efficiency and compliance.
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.
Familiarity with CAD software and testing tools a plus.
Travel & Location
Onsite in Redwood City, CA with flexibility to work in a hybrid capacity.
Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Information Technology
Industries: Civil Engineering
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