We are seeking a Senior System Quality Engineer (Hardware) to lead investigations into hardware-related field failures, drive continuous improvement, and ensure compliance with global regulatory standards.
Requirements
- Deep understanding of hardware engineering fundamentals
- Expertise in system engineering concepts
- Strong knowledge of post-market engineering practices
- Familiarity with manufacturing processes related to electronics, mechanical assemblies, optics, and integration
- Advanced understanding of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and global post-market surveillance requirements
- Proficiency in risk management tools
- Proven ability to lead root cause analysis (RCA)
- Skilled in evaluating failed hardware components
- Expertise in developing and overseeing system-level test plans
- Proficient in statistical methods for trend analysis
- Experience with testing tools such as oscilloscopes, meters, and diagnostic equipment
- Ability to translate customer complaints into engineering hypotheses
- Strong quantitative analysis skills
- Effective communicator capable of explaining complex hardware/system issues
- Collaborative team player
- Strong documentation and technical writing skills
- Ability to manage multiple post-market issues simultaneously
- Project management capabilities to coordinate cross-functional tasks and timelines
- Committed to product safety, regulatory compliance, and ensuring exceptional patient outcomes
- Holistic problem solver who understands interactions between electrical, mechanical, software, optical, and manufacturing elements
- Leads cross-functional investigation teams with confidence and fairness
- Naturally curious and persistent in investigating ambiguous hardware failures
- Builds strong partnerships across engineering, manufacturing, quality, service, and suppliers
- Experience with field service troubleshooting, reliability engineering, HALT/HASS, or environmental testing
- Hands-on experience with optical systems, imaging hardware, robotics, RF, or high-precision mechanical assemblies
- Demonstrated change management experience and ability to guide organizations to desired states
- Willingness to travel as required for technical investigations at customer sites
Benefits
- Comprehensive training and development opportunities
- Annualized base salary range of $98,500-$154,000
- Bonus eligibility
