Job Title: Design Quality / Reliability Engineer
Location(s): New Kensington, PA
(Hybrid: 3 days in office)
Job Summary:We are seeking a Design Quality / Reliability Engineer to support new product development by driving reliability engineering, design quality, and product safety initiatives. This role partners closely with product engineering, manufacturing, and cross-functional teams to improve product robustness, reduce warranty issues, and ensure compliance with medical device quality and regulatory standards.
Key Responsibilities:- Work with product engineering to develop reliability requirements, establish reliability plans, and perform analyses to ensure products meet reliability targets.
- Develop reliability plans outlining required tasks, methods, testing, and analyses for new product development.
- Lead quality initiatives including failure investigations, root cause analysis, corrective actions, and verification to improve product reliability and customer satisfaction.
- Participate in design and reliability reviews to ensure robust product design and manufacturing processes.
- Perform statistical and reliability analyses including:
- Weibull Analysis
- Regression Modeling
- Hazard Analysis
- Reliability Growth Assessment
- Reliability Prediction
- Warranty Trend Analysis
- Spending Forecasting
- Conduct Design Failure Mode and Effects Analysis (DFMEA) and recommend design improvements.
- Partner with manufacturing to evaluate and qualify new technologies and production processes.
- Conduct reliability testing, including:
- Highly Accelerated Life Testing (HALT)
- Highly Accelerated Stress Screening (HASS)
- Accelerated Life Testing at component and system levels
- Validate and track product requirements throughout development.
- Prepare project schedules, work estimates, and technical documentation.
- Provide technical recommendations to improve product quality and reliability.
- Work effectively within cross-functional engineering teams in a fast-paced environment.
Required Qualifications:- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Bioengineering, Software Engineering, or another technical discipline (Master's degree preferred).
- 4+ years of experience in Design Quality, Quality Engineering, or Reliability Engineering.
- Strong expertise in Design Quality, Reliability Engineering, and Product Safety/Compliance.
- Experience with DFMEA, reliability testing, root cause analysis, and statistical analysis.
- Strong analytical, organizational, and communication skills.
Preferred Qualifications:- Electrical or software development experience.
- Materials Science or Plastics Engineering experience.
- Certified Reliability Engineer (CRE).
- Six Sigma Green Belt or Black Belt.
- ASQ certifications such as CQE, CRE, or CMQ/OE.
Regulatory & Industry Knowledge:Experience with medical device regulations and quality standards, including:
- ISO 13485
- ISO 14971
- EU MDR
- IEC 62304
- IEC 60601
- IEC 62366
- MDSAP requirements
Preferred Skills:- Reliability Engineering
- Design Quality
- DFMEA
- HALT/HASS Testing
- Accelerated Life Testing
- Root Cause Analysis
- Statistical Analysis
- Weibull Analysis
- Hazard Analysis
- Reliability Growth
- Warranty Analysis
- Medical Device Compliance
- Risk Management
- Manufacturing Process Qualification
- Six Sigma
Work Environment:- Local Pennsylvania candidates only.
