Principal Design Quality Engineer I (IVD)

TL;DR

Principal Design Quality Engineer I (IVD): Guiding the development and commercialization of in-vitro diagnostic and analytical technologies with an accent on design controls, risk management, and regulatory compliance. Focus on leading verification and validation strategies, solving design-related quality issues, and maintaining traceability across the product lifecycle.

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 instruments 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 risk management documentation, including hazard analyses, FMEAs, and risk-benefit assessments.
• Review engineering specifications, test protocols, reports, design changes, and traceability documentation.
• Drive root cause investigations and corrective and preventive actions for design issues, nonconformances, and field performance.
• Support supplier quality, audits, and continuous improvement of design-related quality processes.

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 involvement in design controls.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVD regulatory expectations.
• Experience with risk management, verification and validation, design documentation, and engineering 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 and handling laboratory equipment, chemicals, or biological materials.

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

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Collaborative, empowered culture focused on customer centricity, ingenuity, ownership, accountability, collaboration, and integrity.
• On-site cafeteria and lunch and snack programs at selected Massachusetts and Maine offices.