What are the responsibilities and job description for the Principal Software Quality Engineer position at Levita Magnetics?
Levita Magnetics is transforming minimally invasive surgery through Magnetic Surgery® and its surgical robot MARS™. We operate in a lean, face-paced environment with a growing pipeline of innovative products.
We are seeking a Principal Software QA Engineer to strengthen our Quality & Regulatory team.
This role provides hands-on technical guidance and quality leadership across all stages of product development, including design, technology transfer, and commercialization. The position is driven by company growth and the increasing complexity of software development, and will play a key role in bridging current quality systems with software needs.
Key Responsibilities
- Represent Quality in new product development, ensuring compliance with company and regulatory standards throughout the product lifecycle.
- Provide hands-on guidance in risk management, usability, and product safety, partnering closely with R&D and Human Factors teams (ISO 14971, IEC 60601, IEC 62366-1), with strong emphasis on software.
- Collaborate with cross-functional teams to define verification and validation strategies, including software validation, and support successful product development and commercialization.
- Ensure design quality and scalability through robust documentation, including software requirements, specifications, test methods, and reliable transfer to manufacturing.
- Lead quality engineering activities including CAPA management, design change assessments (pre and post market), and data analysis to improve product realization processes.
- Support Design History File audits and collaborate with Regulatory Affairs on submissions and compliance activities.
- Contribute to evolving the Quality Management System to better support software development lifecycle needs.
- Partner with and support international teams (including Chile), ensuring strong communication, alignment, and mentorship where needed.
📍 Location: Mountain View, California (Hybrid preferred)
🎯 What we’re looking for:
- BS in Engineering (Software, Electrical, Computer Science or related field), or equivalent experience.
- 10 years in medical device engineering or 5 years with a master’s degree, including 3 years in a Quality role.
- Experience with complex software-driven medical electro-mechanical devices (preferred).
- Proficient in 21 CFR 820, ISO 13485, Design Controls, Document Controls, Risk Management (ISO 14971), and Production/Process Controls.
- Risk management (FMEA, Hazard Analysis), and software-related risk considerations.
- Use of quality tools and statistical programs (e.g., risk assessment, SPC).
- Design spec interpretation and quality issue resolution, including software/hardware interfaces.
- Knowledgeable in Design for Manufacturability, Assembly, and Serviceability.
- Experience defining inspection methods and specifying inspection equipment, including validation approaches for software and systems.
The annual base salary range for this position is from165K-195k.
📩 Send your resume to talent@levita.com with subject “Principal Software QA Engineer"
Benefits may include: medical, dental, and vision insurance, 401(k), paid time off, paid sick leave, and equity compensation. Applicants must be authorized to work in the United States without current or future sponsorship. Employment with Levita Magnetics is at-will. This position complies with applicable federal, state, and local wage laws.
If you require a reasonable accommodation during the application process, please contact talent@levita.com
Levita Magnetics is an equal opportunity employer. We prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex (including pregnancy, childbirth, or related medical conditions), national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment. By submitting your application, you acknowledge that you have read and understood our California Consumer Privacy Act (CCPA) Notice at Collection, which can be found at https://www.levita.com/privacy