VITEK System Engineering Lead

The R&D System Engineering Lead embodies the bioMérieux system development mission by collaborating cross-functionally to develop and support category-leading ID/AST Clinical and Industry solutions that balance user needs, business objectives and technology innovation. We leverage user-centered design and systems engineering methodologies to drive front-end product development and then oversee execution, with a strong focus on product definition, systems architecture, and user experience. Successful candidates will bridge the space between R&D and Marketing, providing critical system engineering leadership.

Who We Want

Driven Leaders. People who have a vision and are natural influencers, able to communicate effectively at all levels, keeping development teams motived and focused on the prize.

User-focused Creators. People that embrace human-centered design to develop products that delight users, improve outcomes, and optimize workflow experience in the laboratory.

Curious Learners. People that desire to expand their boundaries - by working up ideas by hand, or in a laboratory, to test hypotheses and uncover insights that result in new opportunities.

Analytical Problem Solvers. T-shaped contributors who bridge technical domains and are tenacious when faced with an intractable problem, going beyond identifying root causes, carefully evaluating the solution space, and then able to make robust recommendations going forward.

Detail-Orientated Documenters. People who a have a knack for documenting design intent in a written and/ or illustrative form sufficient to inform the development team and support the needs of the Design History File.

What You Will Do

• Collaborate with Program / Marketing / Microbiology / System Development / GCS resources to manage stakeholder needs and product requirements.
• 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 and the functional & technical leads to facilitate system level decision making, arbitrating and using system engineering tools when difficult tradeoffs need to be made document key development decisions and drive consensus when difficult trade-offs need to be made.
• Serve as a liaison between system development and other areas of the organization to coordinate cross functional dependencies and expectations.

Role Requirements

Leadership

• Understand business priorities in order to 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).

Technical – Systems Engineering & User Experience

• Translate/decompose stakeholder 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 system-level design and architecture documents to describe design intent.
• Collaborate with Marketing in Voice of Customer [VoC] and Voice of Stakeholder [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 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.

Business Competencies

• Build a proficiency in ID/AST microbiology products, intended use and clinical workflows.
• Understand project financial models (COGS / ASP / margin / burden / NRE and amortization costs etc.)
• Strategize and execute customer facing activities like voice of customer and customer centric design.

Compliance

• Operate in a regulated environment adhering to applicable standards and regulations that affect the business.
• Expert in full development lifecycle from concept to product release.
• Understanding of agile software development methodologies.
• Familiarity with Human Factors Engineering (HFE), User-Centered Design (UCD) and UX methodologies.
• Knowledge of ISO 13485 and ISO 14971.

Minimum Qualifications

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