Reliability Engineer II

Reliability Engineer II (Through October 2025 // Billerica, MA):

Some flexibility to allow 1 day per week remote

Top 3 Skills Required:

1. Reliability Engineering
2. Test Method Development
3. Test Method Validation

Primary Responsibilities:

• Perform design verification activities including test method development, sample size rationale, and product acquisitions to support all products (as needed).
• Perform test method validation activities using appropriate statistical methodologies.
• Perform reliability activities to resolve product related issues (manufacturing, field complaints, etc.)
• Apply critical thinking to determine the need for further actions or to document audit defendable rationales when no further actions are required.
• Update Risk Management files (Risk Management Report, Product Hazard Analysis, DFMEA, etc.) including risk assessments for projects and issue understanding as needed.

Education Required: Bachelor’s degree in Engineering, Science, or a related technical discipline

Target Years of Experience: 2-4 years

Description:

• Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Completes risk analysis studies of new design and processes.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Ensures that corrective measures meet acceptable reliability standards.
• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
• May develop mathematical models to identify units, batches or processes posing excessive failure risks.
• As necessary, proposes changes in design or formulation to improve system and/or process reliability.
• May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.

Must Have

• Bachelor’s degree in Engineering, Science, or a related technical discipline
• Reliability Testing, Design Verification, and/or Test Method Validation

Nice To Have

• 1-3 years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team