ROLE SUMMARY
The Lead Systems Engineer will work closely with a cross-functional team including clinical operations, manufacturing, engineering, and management to develop the wearable medical device system (including peripherals and accessories). As the Lead Systems Engineer, you will be expected to manage R&D of our product pipeline across all stages of product development starting from requirements and user needs to production and support.
SPECIFIC RESPONSIBILITIES
- Strong understanding of medical device product life cycle and quality system
- Provide system technical leadership in the development of products working with a highly cross-functional team through all stages of product development of a medical device
- Perform in-depth trade-off analyses of technology, systems architecture and design alternatives for new products or platforms
- Lead and develop systems to verify or validate various requirements (system, sub-system)
- Be responsible for leading the implementation of FMEAs, reliability tests and verification and validation efforts in compliance with medical device quality systems
- Engage with external test houses and partners to lead the certification of the product to regulatory standards (e.g. IEC 60601-1, IPC standards)
- Proficient with electronic and software based medical devices (e.g. wearable devices, implantable devices that include electronics)
- Lead the engineering team as the representative for regulatory and notified body presentations and audits
- Proficient in managing internal and external teams, developing, and executing to timelines
- Strong communication skills (verbal & written)
REQUIREMENTS, EXPERIENCE
- BS, MS or Ph.D. in a related engineering or scientific discipline with a preference for advanced degree in Electrical, Mechanical or Biomedical engineering
- 7+ years of systems engineering experience or 10+ years of engineering/R&D experience
- Experience with medical device design and development (21CFR820, EU MDD)
- Proficient in full life-cycle product development methods/activities
- Understanding and application of the standards related to Risk Management and Reliability (e.g. ISO 13485, IEC 60601, ISO 14971, IEC 62366 etc.)
- Experience in creation of failure analysis deliverables, hazards analysis, FMEAs etc.
NICE TO HAVE
- Experience in developing neuromodulation systems
- Experience in regulatory submissions
- Hands-on development experience with test systems
BENEFITS
- Competitive salary & bonus
- Equity in a high-growth startup backed by top-tier VCs
- Medical, vision and dental benefits
- Retirement plan support
- Flexible on-site/remote work options
CONTACT: info@noctrixhealth.com
