Sr Design Quality Engineer, Hardware

BD; United States; Remote; USD 99,000 - 164,000; Full time

Job summary

An established industry player is seeking a Sr Design Quality Engineer to join their innovative New Product Development Team. This pivotal role involves ensuring quality engineering principles are applied throughout the product development lifecycle. You will manage quality control processes, engage in design reviews, and support compliance with regulatory standards. This company values creativity and collaboration, offering a supportive environment for professional growth. If you are passionate about quality engineering in the medical technology field and want to contribute to transformative health solutions, this opportunity is perfect for you.

Benefits

Competitive salary

Health benefits

Professional development opportunities

Performance-based rewards

Qualifications

• Minimum 3 years’ experience in R&D development and Quality Engineering.
• Proficient in quality systems and regulatory standards.

Responsibilities

• Manage quality aspects of design control process and ensure compliance.
• Provide guidance on quality systems and lead CAPA investigations.

Skills

Quality Engineering

R&D Development

Design Control

Root Cause Analysis

Communication Skills

Analytical Problem Solving

Education

BS degree in science or engineering

Tools

Microsoft Office Suite

Quality Systems Standards (21 CFR 820, ISO 13485, ISO 14971)

Job description

Job Description Summary

The Sr Design Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

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.

Duties Include:

• Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts.
• Knowledge of embedded systems design and development, firmware development, and hardware-software integration.
• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
• Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.
• Active participant in the development of product requirement, product system hazard analysis and design reviews.
• Lead/own or support CAPA investigations and CAPA closures.
• Ensure product technical files and Design History Files are complete and auditable.
• Follow Quality System Regulations and established procedures.
• Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.

Qualifications:

• Requires a minimum of a BS degree in science, engineering, or relevant subject area.
• Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Control.

Knowledge, Skills, Abilities:

• Proficient in Microsoft Office suite (Excel, Word, PowerPoint).
• Excellent verbal and written communication skills.
• Ability to work independently as well as part of a team.
• Ability to use root cause analysis tools and execute corrective action plans.
• Knowledge of quality systems and regulatory standards requirements including 21 CFR 820, ISO 13485, ISO 14971.
• Familiarity with GMP and regulatory requirements for medical devices.
• Previous experience in quality engineering role in medical device industry preferred.
• Experience in production and process control is preferred.
• Quality Engineering Certification (ASQ) or equivalent is preferred.

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 https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

#earlycareer

Required Skills

Optional Skills

.

Primary Work Location: USA CA - San Diego TC Bldg C&D

Additional Locations: Work Shift

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:

$99,000.00 - $163,300.00 USD Annual