New Product Introduction Quality Engineer (f/m/d), Wangs

Job Description 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 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).

Primary Work Location CHE Wangs - Straubstrasse

Salary Range CHF83.700,00 - CHF127.650,00 CHF Annual

Equal Opportunity Employer Statement 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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