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Roche

Sr. Systems Engineer RSS (Sequencing)

Summary:
The Sr. System Engineer at Roche Sequencing Solutions (RSS) 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, 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, the System Engineer III 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. ( HPALM/RETINA)
Risk Management: develop system risk portfolio/FMEA/PFMEA and manage all risk reduction activities to ensure full compliance with both Roche internal risk management processes and ISO 14971
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, MD or PhD in a STEM (Science, Technology, Engineering or Math) discipline and Broad Knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems.
6 + years experience in product development for complex electromechanical systems AND 3+ years leading cross-functional teams through technical problem solving and decision-making
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.

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