The RDS R&D Molecular Point of Care (mPOC) Development Chapter is in need of a scientist/engineer with training and work experience in medical device development & validation. You will work as part of a product development technical team and will participate on cross-functional project teams. You will support project team tasks from feasibility phase through system verification & release. You may interface with internal and/or external hardware & software developers, and will work closetly with internal reagent development teams. Experience with FDA regulated system development under design control is a plus. You must be able to manage your own work independently.
Major Job Functions and Contributions
Performs routine or standard technical assignments, which are typically a focused portion of a larger project.
Supports team in product requirements definition and risk assessments. Prepares appropriate technical documentation for product design history files and FDA submissions.
Conducts testing in laboratory to integrate and evaluate reagents, hardware, and software towards assessing feasibility of automated test systems for RUO and IVD and applications
Works as part of a technical team to develop and execute verification test cases and compile associated documentation. Applies technical writing skills to produce reports.
Assesses test results for applicability, validity, and conformance to product requirements.
Assists with technical support tasks (internal and external), such as system installation, troubleshooting, and follow-up, as required.
Presents findings at group or departmental meetings, as required.
Education, Skills and Abilities
Bachelor’s degree in engineering, sciences, or related field required.
3 – 5 years relevant work experience with basic knowledge of system integration principals, concepts, theories. A Master’s degree with fewer years of work experience may be acceptable.
Familiarity with running clinical diagnostic instruments is a plus
Excellent problem solving skills and ability to work with minimal direction
Excellent communication and interpersonal skills
Ability to present technical information clearly in oral presentations
Proficiency in writing technical reports and verbally communicating with other technical staff
Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Pleasanton, CA is $75,000 and $100,000. Actual pay will be determined 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 here:
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits 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.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
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