Design Quality Engineer II – Medical Device Innovation

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

Benefits offered by this job

Medical coverage

401(k) retirement plan

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Design Quality Engineer II to support product development and ongoing operations. You will apply design control principles and quality engineering techniques to ensure compliance with industry standards and regulatory requirements.

The role involves collaboration with cross-functional teams, inspections planning, risk management, and contributing to design input requirements based on historical issues and competitive insights. Travel up to 5% may be required.

Qualifications

• 3+ years of Quality Engineering experience in the medical device industry.
• Must understand FDA and medical device regulations.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.

Responsibilities

• Actively represent Quality on product/process development teams.
• Support design verification, validation, specs, procedures, risk management and design reviews.
• Assist supplier tooling activities and PPAP processes.
• Contribute to root cause analysis and corrective actions for issues.
• Participate in design reviews and prototype testing; ensure manufacturability.
• Develop master test plans and validation methods for product and process testing.
• Identify and manage risk using FMEAs and other risk tools.
• Promote continuous improvement in design control activities across departments.

Skills

Analytical thinking

Communication

Team collaboration

Technical reading

Education

Bachelor’s Degree in Science or Engineering

Tools

Excel

Word

PowerPoint

Job description

CooperSurgical is seeking a Design Quality Engineer II to support product development and ongoing operations. You will apply design control principles and quality engineering techniques to ensure compliance with industry standards and regulatory requirements.

The role involves collaboration with cross-functional teams, inspections planning, risk management, and contributing to design input requirements based on historical issues and competitive insights. Travel up to 5% may be required.