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:

7 years

Schedule:

Monday to Friday

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:

Bachelor's (Required)

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

Bright Uro jobs

Senior Manager, R&D Software (Medical Device)