Job Description

If you enjoy working with solution-oriented, driven colleagues in an agile, bureaucratic-free environment, then come join us at BrightInsight.

Position Summary

The Systems Engineering Lead will utilize an interdisciplinary approach, focusing on customer needs and requirements, and work closely with the development team to design, develop, document and test various software solutions ranging from medical mobile apps to medical-grade cloud-based systems. This position also helps lead the development team from the ambiguity of voice of customer through verification and validation in order to arrive at the best possible solution in a compliant, high quality, and timely manner. This position is responsible for aspects related to product design, development, and maintenance, with focus on requirements, risk analysis, usability, verification, and validation for digital products running on the BrightInsight platform.The BrightInsight platform is a medical IoT cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.

We are looking for someone who thrives in a start-up environment and demonstrates:

Intensely collaborative
Passionately focused on the customer
Disciplined executor of responsibilities
Tenacious commitment to continuous improvement
Relentless drive to win
Intense curiosity on technology
Flexibility and willingness to learn

Here is a glimpse of what you’ll do…

Leads definition of requirements for software-based medical devices, covering functional and non-functional requirements
Works closely with product management to interpret customer, business, and complianceneeds to define technical requirements
Identifies essential and critical requirements, and effectively trace requirements to design and test cases
Learns and understands all the BrightInsight Platform microservices and API interfaces within those microservices in order to effectively trace requirements and design test cases
Leads strategy and definition of high quality and comprehensive system verification and validation
Works with customer, product management, and clinical/medical leads to drive risk analysis activities, including risk management planning, hazard analysis, and risk-benefit analysis
Leads strategy and execution of design reliability

Here is some of what you’ll need (required)…

7+ years of software-based medical device systems engineering experience
Demonstrated applied expertise in FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, IEC 62366, and IEC 62304
Experience in working in an environment following Agile methodology
Demonstrated applied expertise with medical device risk analysis process
Experience leading nearshore and/or offshore development partners
Experience providing technical leadership
Experience launching medical device solutions
Familiarity with health and data privacy regulations

Valid through: 1/30/2021