Design Quality Engineer - Medical Device - Southborough, MA

The Design Quality Engineer will focus on supporting the development of vascular treatment catheters, with a strong emphasis on mechanical, electrical, and software integration for new product introduction (NPI). They will collaborate with R&D to ensure high-quality design and product development, leveraging their dual EE background to address complex technical challenges at our Southborough, MA facility.

Client Details

My client is a medical device company specializing in advanced treatments for atrial fibrillation (AFib), a common heart rhythm disorder. They focus on designing and manufacturing cutting-edge systems that offer precise and effective treatment solutions, particularly for complex cardiac procedures. The company's innovative technology is widely recognized for its ability to improve patient outcomes through customizable, efficient, and high-precision solutions tailored to the needs of electrophysiologists.

With a strong presence in the cardiac ablation space, my client is committed to advancing the field through continuous research and development. They leverage their deep expertise in electrophysiology to create products that optimize energy delivery, providing superior control and effectiveness during procedures. The company is based in Massachusetts and is dedicated to improving patient care through their novel medical solutions.

Description

The Design Quality Engineer (Medical Device Manufacturing) Will:

• Lead Design Assurance activities throughout the product life cycle
• Provide expertise in Risk Management, Design Verification/Validation, Test Method Validation, and Process Validation
• Apply systematic problem-solving methodologies to resolve quality issues
• Stay current on regulatory requirements and standards for medical device development
• Guide engineering team members and ensure adherence to design controls
• Support complaint handling and CAPA processes as needed
• Collaborate with R&D to develop project protocols and solutions
• Work with suppliers and supplier quality teams to ensure product quality
• Develop and implement appropriate test methods and validations
• Oversee statistical methods for design and process optimization
• Ensure compliance with industry standards and best practices
• Perform additional responsibilities as needed for project success
• Be onsite at our Southborough, MA facility daily

Profile

• BS in science or engineering with 5+ years of experience in quality management within medical devices or life sciences. Prefered to have previously worked as a Quality Engineer / Design Quality Engineer for a minumum of 3 years.
• Preferred background in electrical engineering, with experience in US Class III medical devices
• Experience in cardiac electrophysiology devices is a plus
• Strong leadership skills with the ability to manage and guide teams
• Expertise in risk management, design verification and validation, and test method validation
• Knowledge of process validation and preparation
• Proficient in statistical methods and design controls
• Ability to solve complex problems and make data-driven decisions
• Strong communication skills, able to write and speak clearly across organizational levels
• Experience working through the entire product life cycle
• Familiarity with protocols and compliance standards
• Efficient in planning, prioritizing, and organizing tasks and team activities
• Local to Southborough, MA

Job Offer

• Opportunity to work with cutting-edge Class III medical devices
• Growth-focused company with multiple ongoing projects
• Hands-on experience in the medical device field, especially in cardiac technologies
• Potential for career advancement and skill development
• Collaborative and supportive work environment
• Strong company culture with a focus on employee recognition and appreciation
• Exposure to diverse aspects of the product life cycle and regulatory standards
• Opportunity to contribute to the success of innovative medical solutions
• A fast-paced, dynamic work atmosphere with plenty of learning opportunities

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.