- Identify and define internal and external customer needs and translate into functional, performance, usability, and safety requirements for a product or solution
- Develop Use Cases for product or solution based on deep knowledge of users and use environments
- Develop Risk Assessments early in the design cycle using thorough knowledge and understanding of Business, Regulatory, and Design constraints and trade-offs
- Provide technical leadership to the development team to ensure the project successfully meets cost, quality, and schedule targets throughout the product life cycle
- Manage development and decomposition of system level requirements into modules using requirements management tool
- Carry out risk management activities in accordance with EN ISO 14971 throughout product life cycle
- Identify product development issues and facilitate resolution using optimal technology solutions
- Make difficult design or feature trade-off decisions within quality, schedule, and cost constraints
- Lead Usability / Human Factors Engineering activities in compliance with IEC 62366 and FDA guidance
- Apply principles of Reliability and Robustness in the development of products or solutions
- Complete detailed, high quality technical documentation to capture and communicate designs
- Proactively identify and resolve integration issues during developmental tests
- Develop verification protocols with good test coverage
- Coach junior level engineers to perform and excel in the functions of a Systems Engineer
- Bachelor of Science degree in Engineering discipline; 5+ years of product development experience
- Highly proficient in Medical Device product development, FDA Regulations, and MDR
- Working knowledge of IEC 62366 for Usability Engineering
- Proficient in Risk Management with strong understanding of EN ISO 14971
- Experience leading and executing through QFD, Pugh Matrix, CTQ, and DfX activities
- Strong interpersonal skills with the ability to collaborate with others in a team environment
Senior System Engineer - Cincinnati, United States - Vapotherm
Description
Summary
The Senior Systems Engineer at Vapotherm is responsible for the system architecture of a product or solution, from conception to design and through verification and validation. He or she will apply expert technical knowledge and multi-disciplinary engineering principles to translate customer needs into innovative solutions within established medical device regulations and applied standards. This individual will provide guidance to other engineers for technical issues, design reviews, and complex problem resolution using a disciplined approach. He or she will work closely with cross-functional peers in Strategic Initiatives, Marketing, Quality, Regulatory, and Operations while defining and maintaining the system architecture for new devices or sustaining improvements. This individual will stay current with the latest advances in technology and tools and provide valuable input into technology roadmaps to ensure Vapotherm stays at the cutting edge of respiratory care innovation.
Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.
Primary Responsibilities
Position Requirements