Job Description Summary

Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform is responsible for combining design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.

The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Main Responsibilities:

• Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products

• Consistent application of technical principles, theories, concepts and quality sciences / tools

• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

• Contributes to the completion of specific programs and projects

• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers

• Independently determines and develops approach to solution

• May provide guidance and work direction to other team members

• Designs and performs development working independently within defined parameters with minimal supervision required

• Liaise with Manufacturing Plants

• Provide functional support to cross-functional teams

• Define product control strategy

• Lead risk management activities

• Ensure design control elements are satisfied

• Ensure/ perform process validation activities

• Develop/ perform supplier qualification plans have been defined and completed

• Evaluate test methods used in project activities

• Evaluation of customer requirements to identify applicable quality standards

• Release product during development activities

• Realization of quality functional reviews

• Ensure implementation of PS global procedures and standards for QE engineering activities

• Provide support to internal, regulatory body and customer audits and associated corrective actions.

• Develop systems, processes, and procedures related to project quality activities.

• Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share.

• Support customer facing teams by providing technical support from a quality perspective.

• Ensuring the terms on the agreement are met

• Support drafting/updates on customer quality agreements

• Share risk mitigation strategies and control plans for the device with the customers as applicable.

Supports:

• Manufacturing sites with appropriate technological, problem solving, and resources to prevent and or minimize adverse situations.

• Can be part of internal or external quality audit team.

Main Functional Interactions:

Internal:

• Functional core team members R&D, Operations, Medical Affairs, Regulatory Affairs

• Platform (ADDS) leaders

External:

• BDMPS customers, suppliers, and regulatory bodies

Education:

• BS degree in in Engineering, or other scientific discipline

Experience:

• Quality Engineering experience or 12+ years industry experience (Medical Device / Pharmaceutical)

For many 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, weekly testing for COVID-19 may be available instead of vaccination. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

PDN

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift