
Test Engineer - Defined Term
- Wayne, NJ
- $78,000-85,000 per year
- Permanent
- Full-time
- Verification: Ensuring the product meets design specifications.
- Validation: Confirming the product fulfills its intended use in real-world scenarios.
- Test Execution & Oversight
- Lead and mentor technicians in executing test protocols.
- Perform system-level, integration, and regression testing.
- Use automated and manual test methods for both hardware and software.
- Cross-Functional Collaboration
- Work closely with R&D, regulatory, and quality teams.
- Participate in design reviews and risk assessments.
- Provide feedback to improve product design and usability.
- Fixture & Environment Management
- Design and validate test fixtures.
- Set up and maintain test environments for system and subsystem testing.
- Test Planning & Strategy
- Develop and document test strategies, protocols, and plans.
- Align test coverage with system requirements and risk assessments.
- Coordinate with system architects and QA for test case reviews.
- Documentation & Compliance
- Write and maintain traceable test reports.
- Ensure compliance with FDA, ISO 13485, IEC 62366, and other regulatory standards
- Support audits and regulatory submissions with validated test data.
- Bachelor's or Master's in Engineering (Mechanical, Biomedical, or related).
- Potential for limited international travel - must have a valid passport
- Experience in Engineering lab environment, and lab report writing.
- Excellent written, communication and organizational skills, with keen attention to details.
- Strong interpersonal and team skills.
- Advanced proficiency: MS Office Suite including Word, Excel, PowerPoint, and MS Teams
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits