Principal Design Quality Engineer I

NOVA Biomedical GmbH; Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work arrangements

Professional development

Job summary

Nova Biomedical is seeking a Principal Design Quality Engineer I to support development of diagnostic technologies used in clinical care and life sciences. This role ensures IVD products are safe, effective, compliant, and built on robust design principles.

The engineer will partner with R&D, Regulatory, and Manufacturing to guide products through full lifecycle, from concept to post‑market support, emphasizing design controls and risk management.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required.
• 3–7+ years of experience in medical device or IVD product development, with direct involvement in design controls.
• 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-functional.
• Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development.
• Familiarity with IVDR requirements preferred.
• Background in statistics, DOE, or analytical method validation preferred.
• Experience in a fast-paced, early-stage, or growth-stage biotech environment preferred

Responsibilities

• 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 in accordance with 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 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.

Skills

Design controls

Regulatory compliance

Risk management

Cross-functional collaboration

Validation

Documentation

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

DOE

Statistical analysis

Job description

Job Summary:

Nova Biomedical is seeking a Principal Design Quality Engineer I to support the development of innovative, high-performance diagnostic and analytical technologies used in clinical care, critical care, bioprocessing, and life science research. This role plays a central part in ensuring Nova Biomedical’s in‑vitro diagnostic products are safe, effective, compliant, and built on robust design principles.

The Principal Design Quality Engineer I 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.

Responsibilities:

• 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 in accordance with 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 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.

Experience Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required.


• 3–7+ years of experience in medical device or IVD product development, with direct involvement in design controls.


• 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-functional.


• Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development.


• Familiarity with IVDR requirements preferred.


• Background in statistics, DOE, or analytical method validation preferred.


• Experience in a fast-paced, early-stage, or growth-stage biotech environment preferred

Physical Requirements and Working Conditions:

• Able to stand or sit for extended periods.


• Occasional bending, reaching, or movement within lab environment.


• Able to use required personal protective equipment (PPE).


• Willingness to work in a laboratory environment with exposure to chemicals or biological materials.


• Comfort with performing repetitive tasks.


• Capacity to lift and carry up to 25 pounds.


• Manual dexterity required for handling laboratory equipment and instrumentation.

Why work for Nova Biomedical

• Competitive 401k company match


• Bonus Program, Generous PTO and paid holidays


• 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

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.

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.

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.