About us
Bright Uro is a startup, medical device technology company headquartered in Irvine, CA. Our mission is to create meaningful change for millions of people dealing with lower urinary tract symptoms (LUTS) by building the next generation of diagnostic devices for Urology. By utilizing advanced hardware, software, and data science, our goal is to unlock new data streams and offer actionable insight for clinicians while prioritizing the patient experience.
Essential Duties and Responsibilities:
- Lead the development of Bright Uro’s software and firmware technical specifications including accompanying product/non-product software and prototype development
- Lead engineering test, integration, and Verification & Validation (V&V) test efforts including protocol development and documentation of test results
- Collaborate with all relevant departments to achieve a complete software systems Design History File (DHF) and Design Master Record (DMR), as well as, support the transfer of technology to the production team and commercialization efforts of all Bright Uro’s products
- Work closely with other departments such as the Quality & Regulatory Department to ensure compliance with company’s quality system
- Manage and support the development and validation of non-product software systems used in the manufacturing of Bright Uro’s products
- Responsible for managing development partners globally, ensuring on-time delivery of all projects from partners
- Lead or participate in design control activities including writing and/or reviewing design input and design output documents
- Support all document control activities including review and release of design control and related documentation into the company’s electronic Quality Management System (eQMS) to ensure compliance with the company’s quality system
- Manage projects and report status including deliverables, resources, budget, and timeline using well-defined KPIs
- Perform other duties as required to achieve the company’s goals
Education and/or Work Experience Requirements:
- B.S. in Computer Engineering/Science or Electrical Engineering required; graduate degree preferred
- 7+ years of medical device R&D software systems development and testing experience required including experience with building PaaS, SaaS, and/or data platforms
- 5+ years of medical device software development and testing experience required with an in-depth understanding of integrated hardware/software systems development and test methods
- 5+ years of experience in DevOps or agile software development
- Experience in managing cloud-based software development on major platforms such as AWS, Azure, GCP, etc.
- Experience and knowledge of QMS compliance with FDA Title 21 CFR Part 820, ISO 13485:2016
- In-depth knowledge and experience with FDA Software Guidance and IEC 62304 including ISO-14971
- Experience with FDA Cybersecurity Guidance and other applicable cybersecurity-related standards is a huge plus
- Experience with embedded system development and/or debugging involving flexible circuits, signal processing, and sensor hardware is a big plus
- Experience with AI/ML software development including image and/or data processing and DICOM experience is a plus
- Experience with software systems integration projects involving EMR, PACS, or HIS systems is a plus
Additional Requirements:
- High level of personal and professional integrity, trustworthiness, and a strong work ethic
- Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding expectations
- Ability to technically lead, influence, create, and work within cross-functional team environments while being detailed-oriented, communicative, and collaborative
- Ability to work independently, under pressure, and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
- Proven technical leadership characterized by a strong result-oriented approach, a proactive mindset, and a sense of urgency, while embracing changes and challenges that drive the organization forward
Job Type: Full-time
Pay: $120,000.00 - $160,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Unlimited paid time off
- Vision insurance
Compensation package:
- Bonus opportunities
- Stock options
- Yearly bonus
Experience level:
Schedule:
Application Question(s):
- What types of medical devices have you worked on in the past?
- What is your experience with design control activities including writing and/or reviewing design input and design output documents?
- Will you now or in the future require sponsorship for employment visa status (e.g., H1-B)?
Education:
Experience:
- medical device R&D software systems development & testing: 7 years (Required)
- FDA Software Guidance and IEC 62304 including ISO-14971: 5 years (Required)
- DevOps or agile software development: 5 years (Required)
- managing cloud-based software development: 5 years (Required)
Ability to Commute:
- Irvine, CA 92618 (Required)
Work Location: In person
