• 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.

Required Skills and Qualifications
Education

• 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.

Leadership

• 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

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.
• 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.

Compliance

• 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.
• Knowledge of ISO 13485 and ISO 14971