Flex is a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live Smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information please visit our careers page at www.flex.com.
Industry: Electrical / Electronic Manufacturing
Type: Public Company
Headquarters: 2 Changi South Lane, Singapore, 486123
Do you want to want to be part of the Digital Health revolution that’s changing the face of healthcare? Are you passionate about the convergence of the Internet of Things (IoT) and healthcare and the important role that big data and analytics are playing in improving patient outcomes? Then come join us at BrightInsight. BrightInsight, a Flex Company, provides the leading global regulated digital health platform for biopharma and medtech. Our medical-grade Internet of Things (IoT) platform is built under a Quality Management System to support and optimize regulated drugs, devices and software through integrated data and actionable insights to enable customers to drive increased patient adherence and engagement.
We are a start-up comprised of experienced digital health professionals with a mission of making digital health innovation easy for our customers through our end-to-end digital health capabilities and scalable, medical-grade platform.
The BrightInsight Lead Systems Engineer will be based in San Jose, CA, and 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 and timely manner. This position is responsible for aspects related to product design, development, and maintenance, with focus on requirements, system architecture, product risk analysis, usability, change control, and product support for Flex Digital Health platform as well as customer products running on the platform. This position will work closely with the product, development, data science, and operations team to deliver these responsibilities.
We are looking for someone who demonstrates:
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you’ll do:
Interprets customer, business, and compliance needs to define technical design requirements
Identifies essential and critical requirements, and effectively trace requirements to design and test cases
Leads definition of high quality and comprehensive verification and validation strategy
Leads risk analysis activities, including hazard analysis, FMEA, FTA, and risk-benefit analysis
Leads design reliability and strategy
Here is some of what you’ll need (required):
7+ years of software-based medical device systems experience
Experience providing technical leadership
Experience launching medical device solutions
Understands FDA human factors guidance and IEC standards
Familiarity with health and data privacy regulations
Deep understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62366, FDA 21 CFR Part 820, FDA 21 CFR Part 11, FDA design control guidance, and FDA human factors guidance, and application to software-based medical devices
Here are a few of our preferred experiences:
Experience cloud-based medical device systems
Here are a few examples of what you’ll get for the great work you provide:
Full range of medical benefits, dental, vision
Employee discounts at local retailers
Design & TechnologyFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: firstname.lastname@example.org. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
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