Quality Engineer​/Regulatory Specialist

Position Overview

As 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.

• Strategic Quality Leadership
  • Lifecycle 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 Integration
  • Design 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 21
    
    CFR
    820 & ISO
    13485 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 Management
  • Risk 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.

• SW‑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.

• Knowledge 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 product
• Knowledge of mechanical inspection methods and equipment
• Knowledge of SPC, DOE, probability, and statistics
• Ability to solve complex problems to root cause and prevent re‑occurrence (CAPA)
• Ability to read, analyze, and interpret blueprints and GD&T
• Ability to write reports and procedures
• Ability to effectively interact with all levels of the organization
• Ability to develop and maintain strong working relationships with internal and external customers and suppliers.
• Knowledge of Solid Works or other CAD software is desirable
• Detail Oriented
• Good decision‑making skills and judgment
• The ability to execute plans/strategies to completion
• Working knowledge of biocompatibility requirements
• Must be able to travel up to 10% of the time

• Education:
  
  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 (Solid Works/Altium) and modern ALM tools (Jira, Jama, etc.)

• 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 Test Ops, Azure Dev Ops…others
• Mission‑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.