Validation Engineer II — Medical Devices & Life Sciences

MilliporeSigma; Bedford (MA); On-site; USD 84,900 - 127,300; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Bedford, MA is seeking a Product Validation Engineer 2 to join the R&D Validation & Applications Center. You will develop and implement an efficient validation strategy to ensure robust product performance aligned with design and intended applications.

You will author protocols, support DOE studies, and collaborate across functions to drive product development, risk assessment, and test method validations. Occasional travel (<10%) may be required.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or related field with 4+ years of experience in process or product development/validation
• OR Master’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or related field with 3+ years of experience in process or product development/validation
• AND 2+ years of experience with FMEA/risk analysis, product failure and root cause analysis
• 3+ years of experience with IQ/OQ/PQ validations and GDP documentation

Responsibilities

• Author validation test protocols; manage lab test requests, test execution, data analysis, and reporting
• Support DOE studies, data analyses, and creation of product design specs and risk assessments
• Collaborate with Operations, Product Management, and Field Marketing on product/process changes and material qualifications
• Develop and validate new test methods, equipment, and measurement systems for product validation
• Coordinate with R&D, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance groups

Skills

FMEA

GDP

Process validation

Product validation

DOE analysis

Cross-functional

Gage R&R

Minitab

FDA/USP regs

Education

Bachelor’s degree in Chemical/Biomedical/Mechanical Eng or related

Master’s degree in Chemical/Biomedical/Mechanical Eng or related

Tools

Minitab

DOE software

Job description

MilliporeSigma in Bedford, MA is seeking a Product Validation Engineer 2 to join the R&D Validation & Applications Center. You will develop and implement an efficient validation strategy to ensure robust product performance aligned with design and intended applications.

You will author protocols, support DOE studies, and collaborate across functions to drive product development, risk assessment, and test method validations. Occasional travel (<10%) may be required.