Lead Test Engineer (Bioprocess)

Location: On-site in Marlborough, Massachusetts, United States

Annual salary: $85K–$100K, plus eligible bonus/incentive pay.

Company

hirify.global is a Danaher operating company developing solutions for life sciences, diagnostics, biotechnology, biological research, vaccines, medicines, and cell and gene therapies.

What you will do

• Plan verification and validation activities, defining testing scope, approach, resources, and schedules.
• Execute functional, performance, and reliability tests for existing-product line extensions and new product introductions.
• Analyze test results, identify defects, and manage defects through resolution.
• Model and design parts and assemblies in CAD and create or modify drawings.
• Collaborate with development, quality assurance, and project management teams to support product integration and delivery.

Requirements

• Bachelor’s degree in Biomedical, Chemical, or Mechanical Engineering, or a related field, plus 4+ years of post-academic experience in engineering, bioprocess, or a related field.
• Experience working within ISO 9001/13485 and/or cGMP environments.
• Experience with ISO 14971 risk management.
• Knowledge of statistical analysis, DOE, impact assessment, root cause analysis, and risk management/FMEA.
• Understanding of bioprocess engineering principles and methodology.
• Effective written and verbal communication skills and the ability to collaborate across all levels of a global, multidisciplinary team.

Culture & Benefits

• On-site role within the UpStream R&D organization, reporting to the Verification & Validation Manager.
• Benefits include paid time off, medical, dental, and vision insurance, and 401(k) for eligible employees.
• Danaher’s continuous improvement system supports ongoing professional and organizational development.
• Equal opportunity employment and reasonable accommodations are provided in accordance with applicable laws.