28 days agoRoche

Principal Systems Engineer I

  • Santa Clara (Santa Clara)
  • IT development

Job description



·  Job facts

ROLE SUMMARY:

The Principal 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.

The Principal System Engineer will focus on institutionalizing RSS Architecture Definition Process and its implementation. This pivotal role will integrate Systems engineering principles in developing robust and predictable products by establishing methodical model based system definition.

Primary responsibilities include requirements analysis and decomposition, design concept generation, develop architecture viewpoint, relate the architecture to design and remove ambiguity, and manage selected architecture.

In addition, as a part of the Systems Development team, collaborate with the system development peers to establish/manage requirements, conduct and maintain Risk Management portfolio, and contribute in development and execution of design verification and validation activities.

This role will also be responsible for leading cross-functional teams to develop the system of interest and manage it from concept to end-of-life. The range of projects includes but not limited to internally developed products, collaborating with external partners , or outsourced development project. In all cases, the principal System Engineer will be responsible for coherence and compliance of the system development with RSS systems engineering principles and processes.

ESSENTIAL FUNCTIONS:

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The qualified candidate will function at an architect level of systems engineering responsible for the platform on a next-generation sequencing (NGS) platform. This candidate will 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 hardware/software/algorithm performance of the tool.

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Performs Systems Engineering activities including: concept of operations formulation, requirements definition, analysis and engineering, system architecting, system analysis and design, interface and data architectures, validation and verification, systems integration, system & op. performance analysis, Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software or engineering specifications.

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This is a key role responsible for managing internal teams and external development partners. Candidate will interface broadly across project and engineering teams (Mechanical, Electrical, Software, Controls, Embedded); cross functionally with Quality/Regulatory, Clinical, NPI, Service, Test, Project Management, and Marketing; and with various external development teams.

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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.)

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Develop and maintain system Architecture models

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Contributes to Design Transfer activities for product manufacturing, Regulatory Compliance evaluation, and medical device safety certification

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Presents results of projects both internally and externally.

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Reviews and critiques presentation for others; presents complex technical data to large and diverse groups.

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Ability to build a simulation system

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Elaboration of simulation models that enable the simulation of different customer laboratory configurations

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Excellent communication and presentation skills

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Ability to contribute to multiple projects/demands simultaneously

MINIMUM QUALIFICATIONS:

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BS, MD or PhD in Bachelor's degree in a STEM (Science, Technology, Engineering or Math) discipline

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Broad Knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems

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10 + years experience in product development for complex electromechanical systems

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5+ years experience mentoring and guiding other systems engineers in applying best practices and innovating new approaches

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5+ years leading cross-functional teams through technical problem solving and decision-making

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Deep knowledge in at least one discipline, including electrical, mechanical or software engineering.

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Solid background in Systems Engineering processes

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Experience writing requirements documents and design specifications

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Experience developing medical devices within FDA, ISO, and IEC requirements and guidelines including risk analysis and quality assurance.

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Experience developing architecture, requirements and interface artifacts for complex systems

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Experienced in indirectly managing in a matrix organization

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Experience in Conducting Design Verification for IVD systems is essential.

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Experience with NGS workflows, data analysis, systems development is desirable

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Nucleic acid based diagnostics technology background and next-generation sequencing experience are highly desirable.

·  Who we are

At Roche, 94,000 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.