Design Quality Engineer-Medical Device- Northborough, Ma

The Design Quality Engineer is responsible for leading quality system and design assurance efforts during New Product Development (NPI) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and EU Medical Device Regulations for Class III medical devices. This role involves managing design controls, risk management, documentation, and regulatory compliance throughout the product lifecycle.

Client Details

This medical device company focuses on developing advanced solutions for treating cardiac disorders, particularly atrial fibrillation (AFib). With a commitment to innovation, they have successfully treated thousands of patients globally, setting new standards in the field of cardiac care.

Description

As the Design Quality Engineer you will:

• Lead Design Assurance activities across the product life cycle.
• Provide expertise in Risk Management, Design Verification, Validation, Test Methods, Statistical Analysis, and Process Validation.
• Apply problem-solving techniques to address quality issues.
• Stay current on medical device regulatory requirements and standards.
• Guide and mentor engineering teams.
• Support complaint handling and CAPA processes.

Profile

• Strong leadership skills with experience managing teams to achieve goals.
• Skilled in problem-solving, data organization, and maintaining product quality.
• Proficient in task prioritization, goal setting, and team coordination.
• Excellent written and verbal communication across all organizational levels.
• Expertise in quality engineering and medical device standards with training capabilities.

Job Offer

For this candidate, the opportunity includes:

• Leadership Role: A chance to lead and influence quality engineering initiatives within a dynamic organization.
• Professional Growth: Opportunities to expand expertise in medical device standards, regulatory compliance, and advanced quality management systems.
• Impactful Work: Contribute to high-quality, life-changing medical device development and manufacturing.
• Collaborative Environment: Work closely with cross-functional teams in a supportive and innovative culture.
• Competitive Benefits: Attractive compensation, benefits package, and potential for career advancement.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.