Staff Engineer System Design

Company: Otsuka Pharmaceutical Co., Ltd
Location: Palo Alto
Posted on: February 7, 2025

Job Description:

Staff Engineer System DesignApply locations Palo Alto time type Full time posted on Posted 30+ Days Ago job requisition id R7805At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.Position Summary:The Staff Systems Design Engineer will work independently and collaboratively with team members to design, implement, and evaluate engineering solutions in support of new product and technology development as well as process and infrastructure development.Responsibilities and Duties

• Develop, author, and maintain detailed system requirements, architecture, and design documents for new products and technologies.
• Define subsystem specifications and interfaces. Work closely with electrical, mechanical, and software engineering on subsystem implementation and verification.
• Develop system testing methods, author test protocols, guide and perform system test execution, and author test reports.
• Support hazard analysis and failure mode effects analysis of system and subsystems.
• Define and conduct EMC & safety testing per IEC 60601 in conjunction with an external test laboratory.
• Create and maintain comprehensive traceability matrix in Jama.
• Ensure compliance with medical equipment standards (60601, 62304, FDA, MDR, 14971, 13485, etc.).
• Interface with internal QA and RA functions to gain and maintain alignment on system design approach and strategy.
• Prepare, present, and defend technical reviews of system design work. Contribute to technical reviews of colleagues' and team deliverables.
• Collaborate cross-functionally with marketing, quality, regulatory, and operations throughout planning, development, verification, and production.Requirements
• Bachelor's degree in a relevant technical field, Master's degree is a plus.
• Minimum of 8 years' experience developing complex instrumentation and equipment, including RF electronics and embedded real-time controls.
• Experience developing Class III medical capital equipment. Familiar with quality and regulatory requirements, standards, procedures, and documentation.
• Strong technical design background across electrical, mechanical, and software engineering, as well as complex system architecture, specification, and design.
• Strong communication, documentation, and writing skills.
• Works independently with strong initiative, proficient and collaborative across technical areas, leads and drives projects to completion.Salary Range - $176,150- $207,000 (Annual Base Salary)The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.COVID-19 Vaccination RequirementsAt Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all Recor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are > =14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.Equal Employment OpportunityAt Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.
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Keywords: Otsuka Pharmaceutical Co., Ltd, Palo Alto , Staff Engineer System Design, Other , Palo Alto, California