Systems Engineering Leader - San Jose, CA, United States - bioMérieux SA

Description

The estimated salary range for this role based in California is between $189,000 and $227,300 annually.

This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program.

Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

The R&D Systems Engineering team collaborates cross-functionally to develop and support category-leading ID/AST Clinical and Industry solutions that balance user needs, business objectives and technology innovation.

Successful candidates will bridge the space between R&D and Marketing and provide critical system engineering leadership.

Collaborate with Program / Marketing / R&D / GCS / Microbiology resources to manage product requirements, system architecture and design documentation.

Serve as the System Engineering Lead for the project, ensuring that the intent of the design concept is maintained from development through execution.

Partner with the Project Manager, functional and technical leads to facilitate system level decision making, arbitrating and using system engineering tools when difficult tradeoffs need to be made

MS in an Engineering field (Biomedical, Software, Electrical preferred) or equivalent with 8+ years of experience in the medical device industry, or systems engineering/ product development in a regulated industry.

Understand business priorities and help drive system development efforts on large projects with multiple team members.
Technical – Systems Engineering & User Experience
Requirements Management. Translate/decompose user needs into product-level & platform-level functional requirements.
Drive cross-functional alignment on functional specifications (functional leads, technical architects, test engineers, Quality Engineer, etc.)
Create design and architecture documents to describe design intent.
Lead system concept development collaborating with Program, Marketing, Bioscientists, Engineers, UX and Industrial designers.
Leverage user-centered design (UCD) and human factors engineering (HFE) methodologies
Support risk management team in identification of potential failures, mitigations, safety requirements, and design for safety.

Experience working in Agile teams leveraging Scrum, Kanban, or other methodologies with tools such as Jira and/or understanding of Agile development methodologies.

Familiarity with Human Factors Engineering (HFE), User-Centered Design (UCD) and UX methodologies.
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