Experienced Mechanical Engineer Naval Nuclear Laboratory
West Mifflin, PA3 days ago
- $106,200–$166,000 Per Year
ComTec Information Systems
- New Kensington, PA
- 1 day ago
- $65–$85 Per Hour
- Contractor
Highlights
This role focuses on reliability planning, quality engineering, statistical analysis, risk assessment, and product validation to ensure safe, reliable, and high-quality products throughout the development lifecycle. We are seeking a Reliability Engineer to support new product development in a regulated medical device environment.
Numbers & Facts
| Location | New Kensington, PA |
| Job Type | Contractor |
| Salary | $65–$85 Per Hour |
| Company Size | 201 - 500 |
| Year Founded | 1939 |
Description
Reliability Engineer – Medical Devices
Location: New Kensington, PA (Hybrid – 3 days onsite)
Duration: 6 Months
Preference: Local candidates
Job Summary
We are seeking a Reliability Engineer to support new product development in a regulated medical device environment. This role focuses on reliability planning, quality engineering, statistical analysis, risk assessment, and product validation to ensure safe, reliable, and high-quality products throughout the development lifecycle.
Job Responsibilities
Key Responsibilities
Develop and execute reliability plans, testing strategies, and analyses for new product development.
Perform reliability testing, including HALT/HASS, accelerated life testing, and failure analysis.
Conduct DFMEA, root cause analysis, and corrective actions to improve product reliability and quality.
Perform statistical analyses, including Weibull analysis, regression modeling, hazard analysis, and reliability prediction.
Support manufacturing process qualification and technology evaluations.
Validate product requirements and ensure compliance with medical device quality and regulatory standards.
Collaborate with cross-functional teams to drive product quality, reliability, and continuous improvement.
Prepare project estimates, schedules, and technical documentation.
Qualifications
Required Qualifications
Bachelor's degree in Mechanical, Electrical, Bioengineering, Software Engineering, or a related technical discipline (Master's preferred).
4+ years of experience in Reliability Engineering, Design Quality, or Quality Engineering within a regulated industry.
Hands-on experience with DFMEA, reliability testing, root cause analysis, and statistical reliability methods.
Strong knowledge of medical device quality systems and regulatory standards (ISO 13485, ISO 14971, MDR, MDSAP, IEC standards).
Excellent analytical, problem-solving, communication, and project coordination skills.
Preferred Qualifications
Certified Reliability Engineer (CRE), ASQ CQE/CMQ-OE, or Six Sigma Green/Black Belt.
Experience with electrical systems, software development, material science, or plastics engineering.
Knowledge of warranty analysis, reliability growth, and manufacturing process qualification.
Key Skills
Reliability Engineering
Medical Device Product Development
HALT/HASS & Accelerated Life Testing
DFMEA & Risk Management
Root Cause Analysis
Weibull & Statistical Analysis
Reliability Prediction
Quality Engineering
Manufacturing Process Qualification
ISO 13485, ISO 14971, MDR, IEC Standards
Continuous Improvement
Cross-functional Collaboration
Skills
- Reliability Engineering
- Medical device product development
- HALT/HASS & Accelerated Life Testing
About Company
Aerospace
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