Senior Software Quality Engineer – Medical Device​/Embedded Firmware

Senior Software Quality Engineer – Medical Device / Embedded Firmware

Immediate need for a talented Senior Software Quality Engineer – Medical Device / Embedded Firmware. This is a 06+ months contract opportunity with long-term potential and is located in Los Angeles, CA (Onsite).

Pay Range: $50 - $53/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)

Key Responsibilities:

• Partner with R&D as the Quality representative on core product development teams.
• Support quality activities throughout the embedded software/firmware development lifecycle.
• Lead and support software risk management, including Software FMEA (SW FMEA) and system hazard analysis.
• Review software requirements, architecture/design documentation, design outputs, code reviews, verification and validation documentation, and other development deliverables.
• Participate in and facilitate software and system design reviews.
• Ensure software development activities align with applicable design controls, risk management, change control, and Quality System requirements.
• Work with R&D engineers to identify, investigate, document, and resolve software/firmware quality issues.
• Support assessment and disposition of software defects and product issues.
• Author and review risk-management reports, SW FMEA documentation, hazard analyses, and technical firmware issue assessments.
• Collaborate with Regulatory, Medical Safety, Post-Market Quality, and other cross-functional stakeholders.
• Translate complex technical and quality information into clear recommendations for both technical and non-technical audiences.
• Identify opportunities to strengthen software quality processes and drive continuous improvement.
• Support both new product development and sustaining engineering programs.
• Present quality, risk, and technical findings to project teams and stakeholders across multiple organizational levels.

Key Requirements and Technology

Experience:

• Bachelor's degree in Engineering, Science, Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline with 4+ years of relevant experience in Quality, Engineering, and/or Software Development; OR
• Advanced technical degree with 2+ years of relevant experience.
• Experience working in Software Quality, Design Quality, Software Engineering, or Quality Engineering within the medical device industry.
• Strong understanding of the embedded software/firmware development lifecycle.
• Hands-on experience applying quality practices to embedded firmware/software.
• Working knowledge of:
• IEC 62304
• ISO 14971
• ISO 13485
• FDA QMSR
• FDA design controls
• Experience with software risk management, preferably including SW FMEA and/or system hazard analysis.
• Experience with design controls, change control, verification, and validation.
• Experience reviewing software requirements, design documentation, code reviews, and V&V evidence.
• Strong technical writing, analytical, communication, and problem-solving skills.
• Ability to work effectively with R&D and cross-functional teams.
• Experience with medical device embedded firmware or safety-critical software.
• Experience supporting products through new product development and commercialization.
• Experience with Agile development / ALM environments.
• Familiarity with PTC, Jira, or similar engineering/project management tools.
• Experience supporting software-related CAPA, complaint, post-market, or sustaining engineering activities.
• Experience working with FDA-regulated medical device products and quality systems.
• Ability to influence engineering teams and drive quality decisions without relying solely on formal authority.

Our client is a leading medical technology industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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