https://amzn.to/44P6GXZ
You will be part of the System Development & Integration team focusing on development of a next-generation sequencing (NGS) platform. Primary responsibilities include requirements management, risk management, Product Definition, and formal verification and validation of IVD medical systems.The range of projects includes but not limited to internally developed products, collaborating with external partners or outsourced development projects. In all cases you will be responsible for coherence and compliance of the system development with RSS systems engineering principles and processes.
Responsibilities:
Work closely with various subsystems to define the top-level system specifications, allocate requirements to the subsystems, calculate the error budget, define and resolve interfaces and working parameters for the optimal system performance.
Requirements management: Maintain requirements hierarchy and traceability, horizontal and vertical. (RETINA)
Risk Management: develop system risk portfolio and manage all risk reduction activities to ensure full compliance with both Roche internal risk management processes and ISO 14971
Product Definition: Work with Product Definition team and identified Subject Matter expert to align on product definition in order to have a common Source of Truth diagram for Requirement & Specification elicitation.
Assesses different concepts in various dimensions (Requirements coverage, Feasibility/Risks, Reuse of Platform Elements, Development Costs and Time, COGP, Reliability, Modularity/Family Approach, Serviceability, Performance, Innovation etc.)
Contributes to Design Transfer activities for product manufacturing, Regulatory Compliance evaluation, and medical device safety certification
Presents results of projects both internally and externally.
Reviews and critiques presentation for others; presents complex technical data to large and diverse groups.
Excellent communication and presentation skills
Ability to contribute to multiple projects/demands simultaneously
Qualifications/Education required:
Bachelor’s degree plus 6 years relevant experience or Masters plus 3 years relevant experience or PhD in a STEM (Science, Technology, Engineering or Math) discipline as part of combined HW/SW systems.
Experience in product development for complex electromechanical systems and deep knowledge in at least one discipline, including electrical, mechanical or software engineering.
Solid background in Systems Engineering processes
Experience writing requirements documents and design specifications
Experience developing medical devices within FDA, ISO, and IEC requirements and guidelines including risk analysis and quality assurance.
Experience developing architecture, requirements and interface artifacts for complex systems
Experience in developing IVD medical systems is highly preferred.
Nucleic acid based diagnostics technology background and next-generation sequencing experience are desirable.
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
Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Santa Clara, CA is $104,750 and $131,750. 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.
Job Description Description Sigma Defense Systems is a leading technology company serving the Department of Defense (DoD), providing tactical communications...
Apply For This JobJob Description *Job Summary* The Senior Process Engineer supports efforts throughout the company to optimize the operation, performance, and efficiency...
Apply For This JobLearning and Development Specialist Location: Dallas, TX, US For over 70 years, Murata Electronics has been a tireless innovator, committed...
Apply For This JobJob Description Job Summary The job of the Buyer is to administer all procurement-related activities for their area of responsibility...
Apply For This JobEXCITED TO GROW YOUR CAREER? WE’RE GLAD YOU’RE HERE! To function as primary client liaison and lead for assigned programs....
Apply For This JobMontefiore is ranked among the top hospitals nationally and regionally byU.S. News & World Report. For more than 100 years...
Apply For This Job