Principal Reliability Engineer-Medical Device Development

Company Information:

At HiArc, we believe clients don't need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter-around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it. That's why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process-crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won't find anywhere else.

Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.

For more information, please visit HiArc.

OVERVIEW:

The Systems Reliability Engineer is responsible for ensuring the long-term performance, robustness, and durability of medical diagnostic instrumentation. This role focuses on reliability modeling, lifetime testing, failure analysis, and continuous improvement of modules, subassemblies and overall medical instruments. The engineer works cross-functionally with R&D engineers, manufacturing, quality, and the customer R & D and field service teams to enhance product reliability across the full lifecycle.

RESPONSIBILITIES:

Reliability Strategy & Planning

• Develop and implement reliability plans for medical instrumentation
• Define reliability requirements and qualification criteria based on customer requirements and industry standards.
• Perform reliability allocation and prediction (MTBF, FIT rate analysis).
• Develop reliability growth plans and tracking metrics.
• Conduct Reliability Analysis (Reliability Predictions, Failure Mode Effects and Criticality Analysis), Maintainability Analysis (Mean Time to Repair, Mean Time Between Maintenance), Testability Analysis (Built In Test).

Lifetime & Environmental Testing

• Design and execute accelerated life tests (ALT, HALT, HASS) - module and systems levels
• Conduct environmental testing (thermal cycling, humidity, vibration, shock).
• Develop stress screening procedures for electronic, and mechanized mechanical assemblies.
• Establish degradation monitoring protocols

Failure Analysis & Root Cause Investigation

• Lead root cause analysis on development & production instrument / module failures.
• Apply structured methodologies (FMEA, 8D, Fishbone, Weibull analysis).
• Work with suppliers to address component-level reliability issues.

Design for Reliability (DfR)

• Collaborate with R&D during product development to improve:
• Thermal management
• Mechanical / mechanism stability
• Recommend material and component upgrades to extend lifetime

Data Analysis & Reliability Modeling

• Analyze field and test data using statistical tools.
• Perform Weibull and life data analysis.
• Maintain reliability databases

Customer & Field Service Support

• Support field service teams in diagnosing complex failures.
• Analyze warranty trends and customer feedback.
• Provide technical reports on reliability performance.

QUALIFICATIONS:

• Bachelor's or Master's degree in Electrical Engineering, Physics, Systems Engineering, Mechanical Engineering, or related field
• 8 or more years of engineering experience, including a least 3 years in reliability engineering
• Experience with reliability analysis tools (Weibull, Minitab, JMP, ReliaSoft, etc.)
• Familiarity with HALT/HASS methodologies
• Systems Engineering Simulation and Modeling concepts
• Systems Engineering methods and procedures
• Leadership skills in providing guidance to the development, managing the overall reliability effort and customer education and progress
• Strong root cause analysis skills
• Demonstrated skill preparing documents of high quality for customer submittal
• Ability to work to program schedule requirements

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Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule, providing every other Friday off
• Competitive compensation & 401(k) program to plan for your future
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Flexible Vacation & PTO
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identity Theft, Pet Insurance, and more
• Voluntary Tricare Supplement available for military retirees

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

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