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Senior Biomedical Systems Specialist
2 months ago
We are seeking a highly skilled Systems Engineer to join our team at Roche Sequencing Solutions, Inc. in Santa Clara, California. As a key member of our engineering team, you will be responsible for designing and developing new non-invasive and invasive medical device products.
Key Responsibilities- Provide technical expertise to the design and development of new medical device products
- Investigate and evaluate existing technology to inform research and development, regulatory affairs, and reliability engineering
- Select techniques to solve problems and make sound design recommendations for medical device products
- Design and implement new methodologies, materials, machines, processes, or products
- Assess results for applicability, validity, and conformance to Product Requirements
- Conduct feasibility studies to determine ability to function as intended
- Analyze alternative approaches to solve problems and find solutions
- Responsible for Instrumentation and system troubleshooting, risk and requirements management, medical device design verification, test case development, and product development processes in a regulated environment
- Maintain detailed technical documentation of work
- May lead a team of junior engineers to solve discrete engineering problems
- Master's degree in Bioengineering, Biomedical Engineering, or related field and 1 year of experience as a System Engineer, or related role
- Alternative education and experience: Bachelor's degree in Bioengineering, Biomedical Engineering, or related field and 3 years of progressive, post-baccalaureate experience as a System Engineer, or related role
- Special Requirements: Must have 1 year of experience with requirements engineering and design verification specific to biomedical systems, risk assessment, configuration management, structured query language (SQL), and ensuring compliance with medical device regulations (IEC 62304, ISO 13485, ISO 14971, IEC 62366 and 21CFR 820)
We offer a competitive salary range of $109,928 to $132,300 per year, based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
At Roche, we are committed to diversity, equity, and inclusion, and we believe that every voice matters. We are an equal opportunity employer and strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
