Demo

Reliability Engineer II

Redbock - an NES Fircroft company
Billerica, MA Contractor
POSTED ON 1/30/2025
AVAILABLE BEFORE 2/28/2025

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

Salary : $35 - $45

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