Medical Device Quality Software Engineer at Bioness Medical

Santa Clarita, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Sep, 26

Salary

160000.0

Posted On

01 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, FDA 21 CFR Part 820, ISO 13485, Risk Management, CAPA Investigations, Root Cause Analysis, Software Verification & Validation, Embedded Systems Testing, Design Control, Change Control, IQ/OQ/PQ Validation, Internal Auditing, FMEA, QMS Software, EU MDR, MDSAP

Industry

Medical Equipment Manufacturing

Description

WHO WE ARE Bioness Medical Inc. offers innovative neuromodulation medical devices that aid individuals in the recovery from chronic central nervous system disorders such as Stroke, Multiple Sclerosis, Spinal Cord Injury, Traumatic Brain Injury, and others. By fusing breakthroughs in technology with physical medicine and rehabilitation, Bioness is committed to providing patients with new levels of physical independence and productivity. If you are looking for a challenging opportunity that will ignite your passion for helping others, connecting and maintaining cool and innovative services, and you are exceptionally creative, are a great problem solver and can make things happen - apply today! ABOUT THE ROLE The Quality Assurance Software Engineer will be responsible for supporting the development, implementation, and maintenance of quality systems in accordance with FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards. This role will support product development, manufacturing, and post-market activities to ensure compliance and continuous improvement in quality processes. YOUR MISSION: * Support quality assurance activities across the product lifecycle, including design control, risk management, and change control. * Conduct root cause analysis and lead CAPA investigations. * Review and approve validation protocols (IQ, OQ, PQ), test methods, and manufacturing documentation. * Participate in internal audits and support external audits by FDA, ISO registrars, and other regulatory bodies. * Analyze quality data (e.g., nonconformances, complaints, trend analysis) and recommend improvements. * Collaborate with cross-functional teams to support regulatory submissions and ensure quality compliance. * Maintain and improve QMS procedures in alignment with regulatory requirements and company goals. * Lead software verification & validation (V&V) activities. * Create and execute test plans, protocols, and reports * Perform system and integration testing (including embedded systems) * Support risk management and quality processes (CAPA, audits) * Help improve testing and quality processes. SKILLS & ABILITIES) * Bachelor’s degree in engineering, Life Sciences, or related field. * 3+ years of quality assurance experience in the medical device or regulated industry. * Preferred knowledge of FDA QSR, ISO 13485, and risk management per ISO 14971. * Experience with embedded systems or hardware/software testing * Experience with quality tools (e.g., root cause analysis, 5 Whys, FMEA). * Proficiency in Microsoft Office and QMS software (e.g., MasterControl, Greenlight Guru, etc.). * Excellent communication and documentation skills. * CQE, CQA, or related certification a plus. * Experience with Class II or III medical devices. * Familiarity with software validation and/or combination products. * Working knowledge of EU MDR, MDSAP, and global regulatory requirements.

Responsibilities

The role involves supporting quality systems and software verification and validation activities in compliance with FDA and ISO standards. Key duties include leading CAPA investigations, conducting root cause analysis, and managing design and change controls across the product lifecycle.