What are the responsibilities and job description for the Senior R&D Engineer position at Katalyst Healthcares and Lifesciences?
Job Details
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.
- 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.
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