Design Quality Engineer

The company seeks a Design Quality Engineer in Zuchwil, CH, to support new product development for orthopedic implants and trauma/CMF products, ensuring quality system compliance and risk management.

This position supports the New Product Development Design Quality Group for the TECA business, focusing on launching orthopedic implants and associated instrumentation. The role serves as a key contributor within a multi-disciplinary team, providing quality assurance leadership for contract manufacturing sites producing DePuy Synthes products. Additionally, the engineer participates in product development and life cycle management for the Trauma/CMF business.

Responsibilities

• Create standard operating procedures, specifications, and assist with technical transfer and validation.
• Reduce sample and scrap waste, evaluate reliability and risks using validated data, identify root causes of issues, and minimize variation sources.
• Review and approve manufacturing, quality, engineering, and validation documents to ensure compliance with business practices and departmental procedures.
• Collaborate with the regulatory affairs department to conduct initial regulatory reviews of engineering changes and product modifications.
• Develop sampling plans and approve inspection methods for component and product evaluation and testing.
• Provide expertise in reliability planning and demonstrate reliability growth during new product development.
• Support contract manufacturing sites in validation, risk management, product quality issue resolution, escalation, and quality systems performance monitoring for new product introductions.
• Lead design and development planning activities for new projects.
• Participate in creating and executing functional and design requirements for new projects.
• Conduct formal technical design reviews throughout the product development process phases.
• Support and approve design verification and validation activities, including mechanical testing, tolerance analyses, design rationales, and surgeon-based anatomical labs.
• Apply statistical methods and design excellence tools to design verification and validation activities.
• Support risk management activities, including planning, design and clinical risk management, production risk management, and overall risk-benefit reporting.
• Cascade critical-to-quality design features to product quality plans and downstream manufacturing and quality processes.
• Support transfer to manufacturing activities in both product development and base businesses.
• Support product life cycle management activities, such as design changes and cost improvement initiatives.
• Enhance design control and risk management processes to reflect state-of-the-art practices and drive continuous improvement.
• Provide support in all areas of the Quality System, including corrective and preventive actions, product complaints, post-market surveillance, nonconforming materials, risk management, and audit support functions.
• Work closely with suppliers on the qualification of new parts and processes supporting product development.
• Communicate effectively at all levels within Quality and cross-functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
• Follow all laws and policies applicable to the role, maintaining high levels of professionalism, ethics, and compliance.
• Participate in compliance program-related activities as directed by the supervisor or Chief Compliance Officer.
• Communicate business-related issues or opportunities to the next management level.
• Perform other duties as assigned.

Requirements

• Bachelor of Science degree in Engineering and/or Technical Science.
• Minimum of 1 year of experience in a GMP and/or ISO regulated industry (internships, co-ops, or practical experience).

Nice to have

• Experience in new product development or previous experience in a medical device or healthcare discipline is preferred.
• Working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is preferred.
• Blueprint literacy, including GD&T, is preferred.
• Knowledge of process and design excellence tools is strongly preferred; certification is a plus.
• Excellent problem-solving, decision-making, and root cause analysis skills.
• Interpersonal skills that foster conflict resolution in technical situations.
• Ability to embrace teamwork, change, risk-based decision-making, and flexibility.
• Self-motivated to take action.
• Excellent written and verbal communication skills.

About the company

Johnson & Johnson operates with the belief that health is everything. The company's strength in healthcare innovation drives efforts to build a world where complex diseases are prevented, treated, and cured, treatments are smarter and less invasive, and solutions are personal. The organization fosters an inclusive work environment, respecting the diversity and dignity of employees and recognizing their individual merit.

• The company believes health is everything and aims to prevent, treat, and cure complex diseases through healthcare innovation.
• Johnson & Johnson provides an inclusive work environment where each person is considered as an individual.
• The organization respects the diversity and dignity of employees and recognizes their merit.