Senior Quality Engineer- Medical Device- Greater Boston

We are seeking a Senior Quality Engineer with a minimum of 8 years of experience in a regulated industry, specializing in quality engineering for new product development, design controls, and risk management. The role requires expertise in ISO 13485, 21 CFR 820, and IEC 62304, with strong communication, project management, and mentoring skills to support cross-functional teams and ensure compliance throughout the product lifecycle.

Client Details

The company is dedicated to improving patient outcomes by delivering advanced diagnostic technology to electrophysiologists and patients. Their solutions enable patient-specific treatments, addressing the unique needs of the 33 million people affected by atrial fibrillation, where a one-size-fits-all approach does not apply.

Description

• Lead Quality Engineering Innovation: Take the helm in Quality Engineering during the design phase, driving new product development with a focus on development, verification, validation, and transfer, while actively shaping the future of innovative products.

• Shape Risk Management: Be at the forefront of risk management, analyzing and documenting critical insights that influence the entire product development process, ensuring safety and success.

• Collaborate with Cutting-Edge Teams: Work hand-in-hand with dynamic design teams, including software, data science, and hardware experts, to steer the design control process and guide the Software Development Life Cycle (SDLC) toward success.

• Empower Operational Excellence: Play a key role in sustaining engineering, overseeing material control, process development, nonconforming material management, and supplier collaboration to keep operations running smoothly and efficiently.

• Inspect & Elevate Quality Standards: Dive deep into inspecting and testing materials, equipment, and products, ensuring they meet and exceed the highest quality standards-making a direct impact on the final product.

• Drive Quality System Innovation: Design and implement cutting-edge quality system processes that not only comply with regulatory standards but set new benchmarks for excellence.

• Inspire Through Training & Mentorship: Lead exciting training sessions on quality and compliance best practices, mentoring the next generation of QA professionals, and empowering them to excel.

• Audit for Excellence: Be the driving force behind internal audits, ensuring readiness for ISO 13485 certification, and helping the company remain at the top of its game in quality and compliance.

• Master External Standards: Continuously expand your knowledge of external standards, applying them strategically to scale compliance and support the commercialization of groundbreaking products.

Profile

Qualifications & Experience:

• A Bachelor's degree in mechanical, biomedical engineering, or a related engineering discipline.
• Minimum of 8 years of experience in quality engineering or a comparable role within a regulated industry.
• Hands-on experience in software, data science, hardware/systems design, or medical devices, with a solid understanding of Quality Management Systems.
• Deep familiarity with regulatory standards including 21 CFR 820, ISO 13485:2016, and IEC 62304:2006.
• Proven track record in product development, Software Development Life Cycle (SDLC), design controls, and risk analysis.
• Exceptional communication skills, with strong documentation practices, keen attention to detail, and solid project management expertise.

Job Offer

• Career Growth: Be part of a dynamic, innovative team in a growing company where your contributions will directly impact groundbreaking advancements in the industry.

• Challenging Projects: Engage in diverse, high-impact projects within a regulated environment, fostering your expertise in quality engineering and new product development.

• Competitive Compensation: Enjoy an attractive salary package, benefits, and potential performance-based incentives.

• Professional Development: Expand your skills and knowledge with opportunities for training, mentorship, and exposure to cutting-edge technologies and regulatory standards.

• Collaborative Environment: Join a supportive and inclusive workplace that values teamwork, innovation, and excellence.

• Mission-Driven Impact: Contribute to products that make a real difference in improving lives, particularly in advancing healthcare and technology solutions.

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.