Senior Design Quality Engineer

Job Description

Job Description

Join the Innovation Engine at Advanced Instruments, a part of Nova Biomedical

At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care.

Together, we are united by a bold vision : to improve the health of every patient through innovation and excellence . Our mission is to deliver smart, science-driven solutions that optimize processes, increase efficiency, and ensure confidence in results—ultimately leading to better outcomes for patients and providers alike.

Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a growing global presence of 1,965 employees, we’re building an empowered, collaborative culture grounded in our shared values : Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. We’re honoring our founder led legacies—and shaping a future defined by impact.

Explore what’s next with us at http : / / www.novabiomedical.com or https : / / www.aicompanies.com

About the role

This Senior Design Quality Engineer plays a pivotal role in the development and implementation of design processes and quality assurance systems to support our medical and life science instrumentation. The Principal DQE ensures that our products meet both external regulatory requirements and internal company standards.

What we are looking for in you

• Develop and implement quality plans, verification and validation plans, and other quality documents for medical electrical equipment design projects.
• Perform design reviews and risk assessments to identify potential quality and compliance issues
• Collaborate with cross-functional teams to establish and maintain design traceability from requirements gathering through to design outputs and post-market activities in compliance with regulatory standards (such as FDA, ISO 13485, etc.)
• Lead the verification and validation activities for medical devices, including protocol development, testing, and analysis of results driven by new product development and / or product sustainability.
• Manage corrective and preventive actions (CAPA) related to quality issues, includes training and leading quality investigations and routine meetings
• Facilitate the transition of new products from development to production, ensuring adherence to quality standards
• Stay up-to-date with regulatory changes and industry best practices regarding medical device quality assurance

Requirements

Location In office, 5 days per week, Norwood, MA

What's in it for you?

Flexible Medical, Dental, & Vision Coverage

Competitive 401k company match

Bonus Program, Generous PTO and paid holidays

Generous Tuition reimbursement

Professional development, engagement and events

Company marketplace for lunch and snacks!

EEO Statement :

Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Privacy policy

https : / / advancedinstruments.showpad.com / share / DmsEd5QTLlqemTYABlvDW