Systems Engineer

Reports to: Manager, Engineering Position Summary 

The Systems Engineer contributes to the design, development, verification, and validation of new, next generation, and existing products.  S/he plays a key role in the design history file, specifically requirements, verification/validation, and risk management.  S/he works with Clinical and Regulatory Affairs, Operations, Quality, Marketing/Sales and other Fractyl groups to complete projects, meeting performance, quality, and cost goals, while optimizing time to market for Company products. 

Primary Responsibilities 

• Technical Expertise 
  • Work with internal and external stakeholders to establish and maintain stakeholder and system level requirements for new and next generation products. 
  • Translate stakeholder and system level requirements into product architecture and designs, including partitioning functionality across subsystems, creating requirements and specifications for each subsystem, and documenting the interface requirements among the subsystems. 
  • Participate in the development of algorithms, test plans, processes, test fixtures, data acquisition capabilities, etc., in support of on-going product development and testing of complex electro-mechanical, software-driven medical devices. 
  • Perform trade-off analyses in the event of competing design constraints, driving cross-functional team to well-informed decisions. 
  • Generate diagrams, models, prototypes, and data to maintain communication and alignment between stakeholders as the system evolves. 
  • Lead efforts to develop and refine device design, identifying and resolving performance and interface challenges. 
  • Perform risk management, including assessing risks, identifying risk control measures, and ensuring that these control measures are verified to be implemented and effective. 
  • Identify and develop test methods and acceptance criteria for product verification and validation. 
  • Participate in planning for the execution of verification and validation testing, including sample preparation/conditioning and test method validation strategy. 
  • Contribute to the Usability Engineering File, and participate in the efforts of cross-functional team members for deliverables (e.g. voice of customer interviews, formative studies, summative evaluation protocol and report). 
  • Generate design documentation, specifications, risk analyses, verification and validation protocols, and development reports in compliance with Design Control regulations and best business practices. 

• Project Management
  • Identify and prioritize tasks to reduce risk efficiently and continuously.
  • Successfully influence stakeholders through effective communication with cross-functional teams.
  • Schedule and lead Design Reviews at appropriate points in projects. 

• Business Mindset
  • Understand the business impact of engineering requirements and designs.
  • Contribute to the continuous improvement of our systems engineering processes and methodologies.
  • Participate in the development of intellectual property related to the Company products.
  • Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
  • Bring a “can-do” spirit to work and drive assignments to completion. 

Education or Certification Requirements 

• BS in mechanical, biomedical, or electrical engineering or related disciplines required. 

Professional Work Experience 

• 3+ years of engineering experience in product development. 
• Applicable experience in biotech, pharmaceutical and/or medical device industries preferred. 
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.). 

Qualifications and Skills 

• Demonstrable examples of contribution to the design of systems incorporating electromechanical components with feedback systems and preferably fluidics. 
• Evidence of incorporation of user needs shown throughout the design process. 
• Experience working with a requirements management tool (e.g. Helix ALM) is a plus. 
• Comprehensive understanding of Design for Manufacturing and Cost of Goods throughout development cycle. 
• Experienced and knowledgeable about developing products under FDA and European Community medical device regulations and standards, specifically specification development, risk management, and verification/validation. 
• Working knowledge of IEC 62366 and FDA guidance on Usability Engineering in Medical Devices is a plus. 

Other Essentials and Key Success Factors

• Successful track record of working in high-growth and dynamic organizations. 
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit. 
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well. 
• "Hands-on" experience and expertise with concept generation, prototyping, testing, and down-selection. 
• Proven and successful track record as a team-player and collaborator in small working environments. 
• Highly organized and detail oriented with a passion to deliver quality results. 
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation. 
• Highest levels of professionalism, confidence, personal values, and ethical standards. 

Travel 

• May be required to travel as needed. 

The description and requirements outlined above are general; additional requirements may apply.