Job Title: R&D Engineer IIJob Description Join our dynamic R&D team as an R&D Engineer II, where you will play a crucial role in shaping the product's System with a systems-thinking approach. You will be responsible for performing risk management activities, developing design input requirements, and ensuring traceability throughout the product development lifecycle. This position offers the opportunity to contribute to the implementation of an application lifecycle management tool, manage requirements, risks, and verification testing, and engage in new product development projects. Responsibilities + Apply systems-thinking to perform risk management activities and develop design input requirements. + Establish traceability between design inputs and design outputs throughout the product development lifecycle. + Implement and manage an application lifecycle management (ALM) tool for requirements, risks, hazard analysis, and verification testing. + Develop high-quality risk documentation and conduct change impact assessments for new product development projects. + Interface with multidisciplinary teams including quality assurance, regulatory affairs, clinical, and engineering departments. + Conduct system-level hazard analysis and failure modes and effects analyses (FMEA/FMECA) for current design technology and new product development. + Facilitate traceability between design inputs, outputs, and verification using the ALM tool JAMA. + Assess the impact of proposed product design changes and update traceability, regression testing, and documentation as needed. + Author design history file (DHF) deliverables and reports in accordance with internal quality system procedures and external regulations. Essential Skills + Proficiency in risk management, hazardous analysis, FMEA/FMECA. + Experience with design control and traceability. + Knowledge of Application Lifecycle Management (ALM) tools, particularly JAMA. + Ability to develop and maintain risk management files in compliance with ISO and regulatory standards. + Conduct system-level hazard analysis and failure modes and effects analyses. Additional Skills & Qualifications + Initiate document change orders (DCO) in the quality management system (QMS). + Support internal and external audits as required. + Adhere to company goals and objectives, policies, and procedures. + Comply with design controls, standards, and regulations. Work Environment Join a start-up company with approximately 80-100 employees, embarking on an exciting commercialization phase following FDA 510(k) clearance. Be part of the expansion into a second building to grow 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 May 20, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.