{"id":3853616,"url":"https://alion.io/job/planet-pharma-sr-software-quality-engr","title":"Sr Software Quality Engr","company":{"id":4467183,"name":"Planet Pharma","domain":"planet-pharma.com","url":"https://alion.io/company/planet-pharma","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-08T05:47:12Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Java","optional":false},{"name":"Python","optional":false},{"name":"Verification & Validation","optional":false},{"name":"IEC 62304","optional":true},{"name":"ISO 13485","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-10-01T00:00:00Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-08T02:27:19Z","board_verified":true,"closed_at":null,"days_open":38,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":38},"description":"HM’s Top Needs:\nSoftware coding experience (C, Java, Python etc..)\nSoftware Risk Assessment\nSoftware Verification and Validation\nEducation Required:Bachelor’s or Masters in Engineering degree\nYears’ Experience Required: 5 + years\nJob Summary\nThe Senior Software Quality Engineer on the Neurovascular Pre-Market Design Quality team will partner with cross-functional development teams to ensure software and system-level design activities are planned, executed, and documented in compliance with applicable quality and regulatory requirements. This role supports new product development by providing quality oversight and technical guidance throughout the design control lifecycle, with a focus on neurovascular device sizing software as a medical device system.\nThe ideal candidate combines strong systems engineering and software development knowledge with experience in design controls, risk management, verification and validation, and regulatory expectations for medical device development.\nJob Description\nKey Responsibilities\nProvide design quality support for software and software-as a medical device development programs from concept through transfer to manufacturing.\nEnsure compliance with applicable design control, software lifecycle, and risk management requirements.\nReview and contribute to system requirements, software requirements, architecture, and design documentation.\nSupport development of verification and validation strategies for software, system, and integration testing.\nPartner with engineering, product development, regulatory, clinical, and quality teams to resolve design quality issues.\nEvaluate software development deliverables for completeness, traceability, and regulatory readiness.\nSupport risk management activities, including hazard analysis, software-related risk evaluation, and mitigation verification.\nParticipate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.\nAssist in root cause analysis and corrective action activities related to design or software quality issues.\nMentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.\nContribute to continuous improvement initiatives for design quality processes, tools, and templates.\nRequired Qualifications\nBachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.\nDemonstrated experience with design controls, software development lifecycle activities, and verification/validation.\nStrong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing.\nExperience supporting cross-functional product development teams.\nStrong written and verbal communication skills with the ability to influence and collaborate effectively.\nAbility to manage multiple priorities in a fast-paced environment.\nPreferred Qualifications\n5 to 8+ years of experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry.\nExperience in the medical device industry or another highly regulated environment.\nKnowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards.\nFamiliarity with agile development environments and how quality practices integrate into iterative development.\nExperience with AI used in process development and embedded in products.\nExperience with software architecture reviews, cybersecurity considerations, or usability/human factors support.\nAdvanced degree in engineering or a related discipline.\nCore Competencies\nTechnical depth in software and systems engineering\nQuality mindset and attention to detail\nStrong analytical and problem-solving skills\nCross-functional collaboration\nSound judgment and decision-making\nEffective communication and documentation skills\nAbility to coach and influence without direct authority\nThis position plays a critical role in delivering safe, effective, compliant, and high-quality products for our patients and customers by ensuring software and system design activities meet high standards for quality throughout the development 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