BD · 11 hours ago
Engineer II, Quality
USA CA - Irvine Laguna Canyon
Full-time
Onsite
Entry, Mid Level
$81K/yr - $133K/yr
2+ years expBD is one of the largest global medical technology companies in the world. The Quality Engineer II position will support new product development activities within BD’s Advanced Patient Monitoring business unit, ensuring compliance with quality standards and collaborating with cross-functional teams.
Health CareMedical DeviceTechnical Support
Responsibilities
Serves as a Quality representative in cross-functional core teams for NPD programs – primarily around capital hemodynamic monitoring systems
Interprets, applies, and advises on quality aspects throughout the design control process (e.g. requirement management, verification & validation activities, usability / human factors, risk management, etc)
Lead the preparation and maintenance of risk management documentation, Design History Files (DHFs), and other documentation required for regulatory submissions and audits (e.g. test protocols, reports, engineering analysis, drawings, specifications, and operating procedures)
Collaborate closely with cross-functional teams (Mechanical / Electrical / Software / Algorithms R&D, Regulatory, Manufacturing, and Program Management) to ensure design control deliverables meet internal and external standards
Develops test methods and sampling plans using statistical techniques / tools
Coordinates with contract manufacturers and external teams for process development and validation activities
Participates in and supports internal and external audits
Qualification
Required
Bachelor's degree in Engineering (or related field)
Minimum 2 years in medical device industry
Experience with quality system regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485)
Experience in design control, risk management, and verification / validation activities
Strong written and verbal communication skills with the ability to effectively interact with all levels of the organization
Ability to manage multiple projects simultaneously, work independently, and collaborate cross-functionally in a fast-paced environment
Strong analytical, problem solving, and project management skills
Preferred
Experience supporting hardware / software integrated systems
Experience in human factors / usability engineering activities
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-02-09
Company data provided by crunchbase