Position OverviewAs a Sr. Quality Engineer (Level IV) at PSYONIC, you are a technical linchpin bridging the gap between cutting‑edge R&D and scalable Manufacturing. You will architect the quality strategies that ensure our bionic prosthetics and robotic systems are not only revolutionary but clinically robust and globally compliant.This is a mid‑senior leadership role. You will be expected to mentor junior engineers, lead major quality initiatives, and serve as the primary quality voice in high‑priority product development programs.Core ResponsibilitiesStrategic Quality LeadershipLifecycle Architecture: Lead the Quality and Risk Management strategy for Class I, II and III medical devices from concept through commercialization.V&V Strategy: Architect master validation plans. You won't just draft protocols; you will define the methodology for how we prove our clinical & robotics products are safe and effective.Mentorship: Act as a subject matter expert (SME), coaching junior staff on Design Controls, Root Cause Analysis, and technical writing.Design & Manufacturing IntegrationDesign Control Ownership: Own the assigned Design History File (DHF) sections. Ensure seamless traceability from user needs to final verification & validations.Support the development of SOP's, Templates, and other corporate processes in support of the 21CFR820 & ISO13485 Quality Management System development and continuous improvements in the status quo.Supplier & CM Excellence: Partner with Contract Manufacturers (CMs) to establish robust process controls, pFMEAs, and sampling plans.Continuous Improvement: Lead high-impact Complaints, CAPA and SCAR investigations, utilizing advanced statistical methods to prevent recurrence rather than just "fixing" symptoms.Regulatory & Risk ManagementRisk Management Lead: Facilitate dFMEA, pFMEA, and uFMEA sessions, ensuring a "safety-by-design" culture.Submission Support: Provide the technical backbone for FDA 510(k), De Novo, or PMA submissions, translating complex engineering data into regulatory evidence.Functional Track OptionsSW‑Quality Focus: Lead testing strategies for firmware and full‑stack applications. Experience with low‑power devices, software anomaly detection, and IEC 62304 is critical.HW/HG/& Robotics Focus: Focus on mechanical/electrical reliability, biocompatibility, and hardware‑in‑the‑loop (HIL) testing for complex robotic joints and sensors.General RequirementsKnowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.Experience supporting on‑market / commercialized productKnowledge of mechanical inspection methods and equipmentKnowledge of SPC, DOE, probability, and statisticsAbility to solve complex problems to root cause and prevent re‑occurrence (CAPA)Ability to read, analyze, and interpret blueprints and GD&TAbility to write reports and proceduresAbility to effectively interact with all levels of the organizationAbility to develop and maintain strong working relationships with internal and external customers and suppliers.Knowledge of Solid Works or other CAD software is desirableDetail OrientedGood decision‑making skills and judgmentThe ability to execute plans/strategies to completionWorking knowledge of biocompatibility requirementsMust be able to travel up to 10% of the timeQualificationsEducation: B.S. in Biomedical, Mechanical, Electrical Engineering, or Computer Science. (M.S./Ph.D. preferred).Experience: 6+ years in a highly regulated industry (Medical Device preferred; high‑complexity Aerospace/Automotive considered).Technical Mastery:Expert‑level knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820.Proficiency in GD&T, SPC, and DOE.Experience with CAD (SolidWorks/Altium) and modern ALM tools (Jira, Jama, etc.)The 'PSYONIC' Fit (Preferred Qualifications)A "scrappy" mindset. You thrive in a fast‑paced environment and are passionate about making bionic technology accessible to everyone.Robotics Passion: Experience with bionic limbs, orthopedic implants, or complex robotic systems and software is desirable.Advanced SW‑languages & Toolsets: Jam, Linear, Bugzilla, Jira, Jama, Python, C/C++, Rust, Testim, Katalon TestOps, Azure DevOps…othersMission‑Driven: A desire to make advanced prosthetics & robotics affordable and accessible globally.Adaptability: Thrives in a fast‑paced, entrepreneurial environment where self‑starters are rewarded.#J-18808-Ljbffr