Introduction

We are working with a medical equipment manufacturer seeking a Senior Design Quality Engineer to join their team . You will ensure that products meet both external regulatory requirements and internal company standards. You will be the subject matter expert in design traceability, inputs, outputs, verification, and validation.

This role will offer you

• Working with next-generation, class III technology.
• Hybrid work schedule (4 days onsite/1 day from home).
• Ownership of quality processes with upwards mobility.
• Annual Bonus 401(k)

You will be responsible for

• Collaborate with cross-functional teams to establish and maintain design inputs, outputs, and associated documentation in compliance with regulatory standards (such as FDA, ISO 13485, etc.).
• Perform design reviews and risk assessments to identify potential quality and compliance issues.
• Ensure complete design traceability from requirements gathering through to design outputs and post-market activities.
• Develop and implement quality plans, verification and validation plans, and other quality documents for medical electrical equipment design projects.
• Lead the verification and validation activities for medical devices, including protocol development, testing, and analysis of results.
• Facilitate the transition of new products from development to production, ensuring adherence to quality standards.

You will bring the following

• 3 years in a relevant position BS in an engineering capacity.
• Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.).
• Demonstrated expertise in design controls, with a strong focus on design traceability, inputs, outputs, verification, and validation processes.
• Electrical equipment experience is preferred.