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.

Core Responsibilities:

1.    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.

2.    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 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.

3.    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

Functional Track Options:

·        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.

General Requirements:

• 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

Qualifications:

·        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.

o   Proficiency in GD&T, SPC, and DOE.

o   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…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.