Principal Design Quality Engineer I

Principal Design Quality Engineer I Nova Biomedical - 3.4 Waltham, MA Job Details Full-time $120,000 - $160,000 a year 19 hours ago Benefits Paid holidays Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance 401(k) matching Qualifications 3 years Risk management Senior level Communication skills

Full Job Description Nova Biomedical:

One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical , marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets. About the company At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity . Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health. Explore what's next with us at novabiomedical.com or aicompanies.com About the role The Principal Design Quality Engineer I plays a central role in ensuring that our in-vitro diagnostic products are safe, effective, compliant, and built on robust design principles. You will partner closely with R D, Systems Engineering, Regulatory Affairs, and Manufacturing to guide products through the full design and development lifecycle, from concept through commercialization and post-market support. This role is ideal for someone who thrives at the intersection of engineering rigor, quality systems, and hands-on problem solving. What you'll do Serve as the Design Quality representative on cross-functional product development teams, ensuring compliance with 21 CFR 820, ISO 13485, IVDR, and other applicable standards. Lead and maintain Design Control activities, including design plans, design reviews, risk management files, verification/validation strategy, and design transfer documentation. Develop, review, and approve risk management documentation (per

ISO 14971

), including hazard analyses, FMEAs, and risk-benefit assessments. Partner with R D to ensure design inputs are clear, testable, and aligned with user needs and regulatory expectations. Review and approve engineering documentation such as specifications, test protocols, test reports, and design changes. Support verification and validation activities, including method development, statistical justification, and traceability. Drive root cause investigations and corrective/preventive actions (CAPA) related to design issues, nonconformances, and field performance. Support supplier quality activities for design-critical components, including qualification and change assessments. Contribute to continuous improvement of the Quality Management System, with a focus on design-related processes. Participate in internal and external audits, providing subject-matter expertise on design controls and IVD product development. Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVD-specific regulatory expectations. Experience with risk management, verification/validation, and design documentation. Ability to interpret engineering drawings, specifications, and test data. Excellent communication skills and comfort working cross-functionally. Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development. Familiarity with IVDR (EU 2017/746) requirements. Background in statistics, DOE, or analytical method validation. Experience in a fast-paced, early-stage or growth-stage biotech environment. What we are looking for in you List Qualifications/Requirements for role Bachelor's degree in Engineering, Life Sciences, or related technical field. 3-7+ years of experience in medical device or IVD product development, with direct involvement in design controls. Physical Requirements for this role include: Ability to work in an office, laboratory, and light manufacturing environment as needed. Ability to sit or stand for extended periods while reviewing documentation, participating in meetings, or supporting lab activities. Ability to lift, carry, or move equipment, test fixtures, or materials up to 25 lbs occasionally. Ability to perform hands-on tasks such as inspecting components, handling small parts, or supporting test setups that may require fine motor skills. Ability to wear appropriate PPE (e.g., lab coat, gloves, safety glasses) when working in laboratory or production areas. Ability to move between different work areas, including R D labs, production floors, and meeting spaces. Visual acuity sufficient to read engineering drawings, specifications, and test data, both on screens and on paper. Occasional travel (up to 10%) to suppliers, manufacturing partners, or other company sites may be required. The full list of physical requirements for this role is available upon request. Why work for Nova Biomedical Flexible Medical, Dental, & Vision Coverage Competitive 401k company match Bonus Program, Generous PTO and paid holidays Generous Tuition reimbursement Hybrid and flexible work arrangements Professional development, engagement and events Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices Company subsidized cafeteria in our Waltham, MA office

Work Location:

Hybrid work schedule on-site in

Waltham, MA Targeted Salary Range:

$120,000 - $160,000/year. Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.

EEO Statement:

Nova Biomedical 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, Nova Biomedical 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.

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