Design Quality Engineer II - Medical Devices

Regulatory Jobs; Trumbull (CT); On-site; USD 78,000 - 100,000; Full time

Job summary

CooperSurgical is seeking a Design Quality Engineer II to provide design quality engineering support across product development and operations. You will ensure design controls, verification, validation, risk management, and design reviews meet regulatory requirements and customer expectations.

Collaborating with cross-functional teams, you will contribute to prototype evaluation, testing, and documentation to enable manufacturability and testability, while addressing quality-related challenges

Qualifications

• Bachelor's Degree or higher in Science or Engineering (or related field).
• Strong analytical and problem-solving skills with attention to detail.
• Experience collaborating with cross-functional teams in a medical device development environment.

Responsibilities

• Actively represent Quality function on product/process development teams.
• Support engineering teams to ensure design control requirements are met (verification, validation, specs, procedures, risk management, design reviews).
• Support supplier tooling activities and PPAP tools to ensure components qualify on time.
• Participate in investigations of product and process issues and contribute to root cause analysis and corrective actions.
• Participate in design reviews and provide quality feedback.
• Develop master test plans and validate product and process test methods.
• Identify and manage risk using FMEA and other tools throughout development.
• Promote continuous improvement in design control activities and tools.
• Comply with FDA and international regulatory requirements and Cooper's Code of Conduct.

Skills

Analytical skills

Communication

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Tools

Excel

Word

PowerPoint

Job description

CooperSurgical is seeking a Design Quality Engineer II to provide design quality engineering support across product development and operations. You will ensure design controls, verification, validation, risk management, and design reviews meet regulatory requirements and customer expectations.

Collaborating with cross-functional teams, you will contribute to prototype evaluation, testing, and documentation to enable manufacturability and testability, while addressing quality-related challenges