We are the people who give possibilities purpose

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.

Job Description

Job Responsibilities:

• Collaborate with R&D, Manufacturing, and Regulatory teams to define quality requirements and ensure their incorporation into new product designs and processes.

• Develop and implement quality plans, including design verification and validation strategies, for existing medical devices.

• Conduct risk assessments (e.g., FMEA) and support the establishment of appropriate risk mitigation strategies throughout the NPI process According to ISO14971.

• Participate in design reviews, providing expert quality input and ensuring adherence to design control procedures and relevant medical device regulations (e.g., ISO 13485, FDA QSR).

• Develop, review, and approve product specifications, test protocols, and inspection plans for existing products.

• • Oversee and perform Gage R&R studies and process capability analyses for new manufacturing processes.

• Support the qualification of new suppliers and components, ensuring they meet Straub Medical AG's quality standards.

• Investigate and resolve quality issues identified during development, testing, and early production phases.

• Ensure smooth transfer of new products from development to manufacturing, including the establishment of quality control points and documentation.

• Maintain comprehensive documentation for all NPI quality activities in accordance with quality management system requirements.

• Contribute to continuous improvement initiatives within the NPI and Quality departments.

Job Qualifications:

• Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related technical field.

• Experience in Quality Engineering within the medical device industry, with a strong focus on New Product Introduction (NPI) or product development.

• In-depth knowledge of medical device regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820).

• Proven experience with design controls, risk management (FMEA), design verification, and process validation (IQ, OQ, PQ).

• Strong understanding of statistical process control (SPC) and other quality assurance methodologies.

• Excellent problem-solving skills and the ability to conduct root cause analysis.

• Proficiency in technical report writing and documentation.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.

• Certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt are a plus.

• Fluency in English (written and spoken).

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

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.

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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