Principal Design Quality Engineer I - IVD

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

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.