Job Title: R&D Engineer, Risk Management

Job Description

Join our dynamic R&D team as an R&D Engineer II, where you will play a crucial role in the development of our product's system. This position focuses on applying a systems-thinking approach to perform risk management activities, develop design input requirements, and establish traceability throughout the product development lifecycle. You will also contribute to the implementation of an application lifecycle management tool to manage requirements, risks, hazard analysis, and verification testing.

Responsibilities

• Perform risk management activities and develop design input requirements.
• Establish traceability between design inputs and design outputs.
• Contribute to the implementation of an ALM tool for managing requirements and risks.
• Develop a strong understanding of current design technology.
• Participate in new product development projects.
• Establish high-quality risk documentation and conduct change impact assessments.
• Interface with quality assurance, regulatory affairs, clinical teams, and other engineers.
• Develop and maintain risk management files in accordance with ISO and regulatory standards.
• Conduct system-level hazard analysis and FMEA/FMECA for current and new designs.
• Facilitate the implementation of the JAMA ALM tool for traceability management.
• Assess the impact of proposed product design changes on requirements, risks, and verification.
• Author DHF deliverables and reports as per internal and external regulations.

Essential Skills

• Proficiency in risk management and hazardous analysis.
• Experience with FMEA/FMECA and design control.
• Knowledge of traceability and application lifecycle management.
• Ability to develop and maintain risk management files.
• Experience in conducting system-level hazard analysis.
• Proficiency in using JAMA for managing design traceability.
• Ability to assess the impact of design changes and update documentation accordingly.
• Experience in authoring DHF deliverables.

Additional Skills & Qualifications

• Initiate document change orders in the QMS.
• Support internal and external audits.
• Adhere to company policies and procedures.
• Comply with design controls and regulatory standards.

Work Environment

Join a vibrant start-up environment with a team of 80-100 individuals. The company has recently received FDA 510(k) clearance and is entering the commercialization phase. We are expanding into a second building to enhance our R&D and manufacturing capabilities.

Pay and Benefits

The pay range for this position is $126700.00 - $163000.00/yr.

Medical, Dental, Vision, 401k, PTO 3 weeks, Stock Options

Workplace Type

This is a fully onsite position in Sunnyvale,CA.

Application Deadline

This position is anticipated to close on Jun 26, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.