Engineer II, Quality

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Quality Engineer II position will support new product development (NPD) activities within BD's Advanced Patient Monitoring (APM) business unit.

Job 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

Minimum Requirements:

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 Requirements:

Experience supporting hardware / software integrated systems

Experience in human factors / usability engineering activities

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

Primary Work Location
USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift
NA (United States of America)

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information
$80,600.00 - $133,000.00 USD Annual