Business & Product Overview: 

Pyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process. At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system. Learn more about Pyxis®: https://www.bd.com/en-us/products-and-solutions/products/product-brands/pyxis 

Broader Duties for this role include: 

• Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts.

• 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.

• Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval

• Drive continuous improvements in QMS activities as it relates to software development lifecycle including post market through facilitating, leading, and collaborating with cross functional teams

• Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.

• Identify gaps & improvement opportunities to ensure effective verification and validation of design specifications and requirements.

• Active participant in the development of product requirement, product system hazard analysis and design reviews.

• Works collaboratively to drive root cause analysis of failures, CAPA and use structured problem solving for product development and manufacturing issues.

• Support internal and external audit activities as it pertains to software quality processes

• Ensure product technical files and Design History Files are complete and auditable.

​What is expected of you for success in your role:

• Demonstrates strong knowledge of quality engineering policies, principles and best practices

• Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities

• Applies comprehensive knowledge of software quality concepts within the software development lifecycle

• Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

• Applies knowledge and skills to a wide range of situations

Desired Characteristics:

• Software development experience within a regulated environment

• Strong background in software development methodologies

• Prior experience with supporting external audits with FDA, BSI, TUV etc

• Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications

• Thorough understanding of the risk management and quality by design

• ASQ Certified Software Quality Engineering Certification (CSQE) or equivalent

• Attentiveness to details with strong organizational skills

• Ability to work proactively and independently

• Ability to manage multiple priorities and be efficient in time management

• Excellent verbal communication and interpersonal skills with the ability to work in a team environment

• Proficiency in Excel, Word, and other desktop/general business systems

Qualifications: 

• Qualified candidates will have a bachelor’s degree in a relevant degree field (engineering) 

• Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls 

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. 

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