Design Quality Engineer

Michael Page; Hudson (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary

Opportunities for career growth

Comprehensive benefits package

Engaging work environment

Job summary

A leading recruitment agency is seeking a Design Quality Engineer in Hudson, Massachusetts. The role focuses on leading design assurance for new product development, ensuring compliance with FDA and ISO standards. The ideal candidate has a B.S. in engineering, 5+ years of experience in quality management within the medical device sector, and strong skills in risk management and documentation. This position offers a competitive salary, career growth opportunities, and a supportive environment.

Qualifications

• 5+ years of quality management experience in medical devices or life sciences.
• Strong knowledge of design quality and regulatory standards.
• Experience with risk assessment and management in engineering and manufacturing processes.

Responsibilities

• Ensure compliance with regulatory and quality standards during the design and development process.
• Collaborate with cross‑functional teams to identify and resolve design‑related quality issues.
• Conduct risk assessments and implement effective risk management strategies.
• Support validation and verification activities for new products.
• Analyze quality data to identify trends and implement corrective actions.

Skills

Quality engineering

Medical device regulations

Risk management

Documentation

Cross-functional communication

Education

B.S. in a science or engineering field

Job description

Join to apply for the Design Quality Engineer role at Michael Page

Base pay range

$110,000.00/yr - $140,000.00/yr

The position leads design assurance activities for new product development, ensuring full compliance with FDA, ISO, and global medical device regulations. It drives quality engineering efforts across the product lifecycle, including risk management, verification/validation, and process validation, while supporting cross‑functional teams and suppliers.

This company is a long‑established medical device innovator focused on advancing treatment for atrial fibrillation through endoscopically guided and pulsed field ablation technologies. Their portfolio includes multiple generations of balloon‑based ablation systems that provide direct visualization and precise energy delivery for cardiac procedures. The company also develops and manufactures systems used globally across hospitals and electrophysiology labs.

Description

• Ensure compliance with regulatory and quality standards during the design and development process.
• Collaborate with cross‑functional teams to identify and resolve design‑related quality issues.
• Conduct risk assessments and implement effective risk management strategies.
• Develop and maintain documentation for design control processes.
• Participate in design reviews and provide quality input to ensure product reliability.
• Support validation and verification activities for new products.
• Analyze quality data to identify trends and implement corrective actions.
• Stay updated on industry standards and regulations to ensure ongoing compliance.

Profile

• B.S. in a science or engineering field.
• 5+ years of quality management experience in medical devices or life sciences.
• Strong knowledge of design quality and regulatory standards.
• Experience with risk assessment and management in engineering and manufacturing processes.
• Proficiency in maintaining and developing design control documentation.
• Knowledge of validation and verification methodologies.

Job Offer

• Competitive salary ranging from $110,000 to $140,000 USD.
• Opportunities to work in a small‑sized company.
• Potential for career growth and professional development.
• Engaging and supportive work environment.
• Comprehensive benefits package.

Desired Skills and Experience

• Strong knowledge of quality engineering and medical device regulations.
• Experience in design controls, risk management, and verification/validation.
• Skilled in problem‑solving, documentation, and cross‑functional communication.
• Ability to lead quality initiatives and guide engineering teams.
• Familiarity with Class III devices and cardiac electrophysiology.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Engineering, Manufacturing, and Quality Assurance

Industries

• Manufacturing

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.

If you are passionate about ensuring design quality in engineering and manufacturing and are looking for a rewarding role, we encourage you to apply today!