Design Quality / Reliability Engineer

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

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.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.