Research And Development Engineer

Curt Koland Recruiting is currently seeking candidates who are passionate about developing medical technologies to improve patient outcomes. Our client is a medical device innovator focused on a flagship all‑in‑one endoscopic platform that integrates visualization, fluid management, and tissue removal into a single system. This is an exceptional opportunity to join a dedicated team at a pivotal moment in the company's growth.

We are looking for candidates currently living in the San Francisco Bay Area with 5 or more years of experience in the Medical Device industry or a closely related field. Candidates must possess either US Work Authorization or US Citizenship. We are not able to accommodate H‑1B Visa transfers at this time.

We are seeking a talented and motivated R&D Engineer for this full‑time on‑site position offering hands‑on experience with cutting‑edge medical device technology. In this role, you will be a key contributor to the development of the company product, working closely with multidisciplinary engineering and operational teams.

• Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QS Regulation, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations.
• Responsible for ensuring proper documentation consistent with company’s quality system.
• Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.
• Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
• Develop solutions to design problems through the application of engineering principals, analysis, and empirical methods.
• Model complex components and assemblies in CAD and create detailed drawings.
• Build and test prototype designs for proof of concept.
• Develop protocols and perform product verification and validation testing.
• Perform process‑related design tasks to support pilot manufacturing.
• Support production of final product by troubleshooting manufacturing processes.
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
• Maintain GMP systems, including pre‑production quality assurance procedures, pre‑clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

• Bachelor's in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical field.
• 5+ years of professional experience in the medical device industry or similarly regulated industry.
• Must possess good interpersonal and communication skills, and work in a collaborative style.
• Good technical skills and proven engineering problem solving ability.
• Experience using CAD tools (Solid Works preferred).
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Able to perform engineering design analysis such as FEA, FMEA, dFMEA, and tolerance stack‑up analysis.
• Able to create timelines for projects from concept to commercial release.
• Able to work with contract suppliers to update or troubleshoot manufactured product.

• Proven ability to perform both In‑Vitro and In‑Vivo testing for R&D development.
• Direct experience with the design and development of handheld devices or surgical tools.
• Strong product design experience, specifically working with metal components or injection‑molded materials.

This is a full‑time, on‑site role in the Bay Area focused on hands‑on development and rapid iteration. While we value work‑life balance, the pace of our development occasionally requires flexible hours to meet critical milestones.