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- Collaborate with Program / Marketing / R&D / GCS / Microbiology resources to manage product requirements, system architecture and design documentation.
- Participate in the feasibility of new products or product evolutions coordinating development of system level concepts and system architecture.
- 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
- Serve as a liaison between system development and other areas of the organization to coordinate cross functional dependencies and expectations.
- 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.
- Effectively communicate & rationalize decisions/issues to the cross-functional team & leadership stakeholders.
- A natural ability to communicate, build relationships (based on trust) and to influence peers (strong levels of command and courage).
- Strong sense of accountability and ownership, with a track record of delivering results
- Strong interpersonal and communication skills, both verbal and written, with an aptitude towards customer support
- Track record of being a self-starter and strong independent contributor
- 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.
- Collaborate with Marketing in VoC and VoS activities and lead user needs capture and screening.
- 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
- Proactively solve design problems at a system and product level; may be called upon to lead a cross-functional team to solve challenging technical and/ or usability problems.
- Support risk management team in identification of potential failures, mitigations, safety requirements, and design for safety.
- Operate in a regulated environment adhering applicable standards and regulations that affect the business such as Design Control
- 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.
Lead Systems Engineer - 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. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. 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.
Position Summary
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.
Required Skills and Qualifications
EducationLeadership
Technical – Systems Engineering & User Experience
Compliance