Medical Device Senior Software Design Quality Engineer

Summary: As a Senior Software Design Quality Engineer in the medical device industry, you will play a pivotal role in ensuring the highest quality and compliance of software systems used in medical devices. You will be responsible for designing, developing, and implementing quality assurance strategies to ensure that software meets regulatory standards and customer expectations. Your expertise will guide the team through rigorous testing processes, risk management, and validation activities.

Key Responsibilities:

• Lead DQA project teams by working with Product Development Engineers (embedded within R&D) to create / review Hardware/Software systems including Cyber security and identify possible failure modes/risk control opportunities for these complex systems (FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected and cloud-based software systems).
• Review of SW/HW sub-systems (PCBA’s, FPGAs, with and without Firmware, etc.) and identify risk control measures
• Review of part schematics for identification or risk control measures
• Recommend updates to design prints or added tests as a result or risks identified
• Partner with R+D team members and own the identification of risk-based requirements definition within the Quality System (21 CFR 820/ ISO13485) for the Medical Device Software process, IEC 62304
• Meet company and applicable Standards, based on risk controls identified
• Review of requirements vs risks to define where the appropriate level of risk control lies
• Own the creation and maintenance of risk management and usability documentation such as, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Fault Tree Analysis (FTA) incorporating both IEC 62304 and Cybersecurity principles.
• Participate in the creation and/or review of Software documentation (Software Development Plan, Detailed Design, safety class, etc. (required per IEC 62304) and Threat Modeling / Security Risk Analysis)
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Requirements:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Electrical Engineering, or a related field
• Minimum of 5-8 years of experience in software quality assurance in the medical device industry
• Strong knowledge of software development lifecycle (SDLC) and software testing methodologies
• Experience with regulatory requirements specific to medical devices (e.g., FDA, ISO 13485, IEC 62304)
• Proficiency in testing tools, scripting languages, and automated testing frameworks.
• Excellent problem-solving skills and attention to detail
• Strong communication skills, both verbal and written
• Ability to work effectively in a fast-paced, collaborative environment

Note: Third party resumes will not be accepted for this role.