Principal Design Quality Engineer I (IVD)

Location: Hybrid work schedule on-site in Waltham, Massachusetts, United States

Salary: $120,000–$160,000 per year

Company

hirify.global develops diagnostic and analytical technologies for clinical care, bioprocessing, biotechnology, and life science research.

What you will do

• Represent Design Quality on cross-functional product development teams from concept through commercialization and post-market support.
• Lead design control activities, including design plans, reviews, risk files, verification and validation strategies, and design transfer documentation.
• Develop and approve ISO 14971 risk management documentation, including hazard analyses, FMEAs, and risk-benefit assessments.
• Review design inputs, specifications, test protocols, test reports, and engineering changes with R&D and Systems Engineering.
• Support verification and validation, method development, statistical justification, and traceability.
• Drive root-cause investigations, corrective and preventive actions, supplier quality assessments, continuous improvement, and audits.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 3–7+ years of experience in medical device or IVD product development with direct design control involvement.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVD regulatory expectations.
• Experience with risk management, verification and validation, design documentation, engineering drawings, specifications, and test data.
• Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent and consumable development.
• Ability to work in a hybrid schedule on-site in Waltham, Massachusetts, including laboratory work with chemicals or biological materials and lifting up to 25 pounds.

Nice to have

• Familiarity with IVDR requirements.
• Background in statistics, design of experiments, or analytical method validation.
• Experience in a fast-paced, early-stage, or growth-stage biotech environment.

Culture & Benefits

• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Flexible and hybrid work arrangements.
• Collaborative culture focused on customer centricity, ingenuity, accountability, collaboration, and integrity.