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)
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 projects. 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.
- The qualified 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.
- 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.
- 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).
- 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
- BS, MD or PhD in Bachelor's degree in a STEM (Science, Technology, Engineering or Math) discipline
- Broad Knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems
- 10 + years of experience in product development for complex electromechanical systems
- 5+ years of experience mentoring and guiding other systems engineers in applying best practices and innovating new approaches
- 5+ 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
- Experienced in indirectly managing in a matrix organization
- Experience in developing IVD medical systems is highly preferred.
- Experience with NGS workflows, data analysis, systems development is desirable
- Nucleic acid based diagnostics technology background and next-generation sequencing experience are desirable.
Roche is an equal opportunity employer.Technical Development, Technical Development > Medical Device Technology Development