51 минуту назад
Sr Engineer (Medical Device Reliability)
85 000 - 95 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr Engineer (Medical Device Reliability) (Medical Devices): Planning, designing, executing, and analyzing reliability tests for new medical device products and product changes with an accent on electromechanical systems, regulated documentation, and reliability data analysis. Focus on developing QALT and life-testing protocols, fabricating test fixtures, investigating field failures, and demonstrating product reliability to quality and regulatory standards.
Location: Hybrid role with three days per week in Warrendale, Pennsylvania, United States
Salary: $85,000–$95,000 per year
Company
is a medical technology company developing and supporting healthcare products in a regulated environment.
What you will do
- Plan, design, execute, document, and analyze reliability tests for new products and product changes.
- Develop and execute test protocols, including Quantitative Accelerated Life Testing and Reliability Life Testing.
- Design, fabricate, maintain, and qualify reliability test fixtures and equipment.
- Analyze test results, defects, field failures, and reliability metrics using structured data and test databases.
- Support root cause analysis, troubleshooting documentation, technical reviews, and compliance documentation.
- Collaborate with Hardware, Sustaining, Systems, Quality, Regulatory, and R&D teams.
Requirements
- Bachelor’s degree in Engineering or equivalent experience.
- At least three years of hands-on experience as a reliability engineer or systems test engineer on product development teams.
- Experience with electromechanical assemblies, complex mechanisms, reliability testing, test design, and engineering documentation.
- Experience using PLM systems to manage documentation revisions in accordance with FDA requirements.
- Strong data analysis, troubleshooting, test protocol development, technical writing, and presentation skills.
- Must be authorized to work for any employer in the United States; visa sponsorship is not available now or in the future. Effective English communication is required.
Nice to have
- Weibull and reliability statistics, accelerated life testing, DFMEA, ISO 14971, and medical device design controls.
- Experience with Minitab, JMP, ReliaSoft Weibull++, MATLAB, Python, Excel, Access, Windchill, or requirements management tools.
- SQL, project planning, mentoring junior engineers and technicians, and experience justifying reliability strategies to management and regulators.
Culture & Benefits
- Collaborative work across Hardware, Systems, Quality, Regulatory, and R&D functions.
- Medical, prescription drug, dental, and vision coverage.
- 401(k) plan with company contributions, life insurance, disability coverage, and wellness programs.
- Paid vacation, holidays, and personal days, plus an employee assistance program.
- Work is performed in a hands-on development laboratory within a regulated quality and safety environment.
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