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Job Title:

Sr. Development Engineer IV

ME | EE | SW-Embedded | SW-App/DB | Eng. Proj. Manager

Position Overview:

The Development Engineer IV at PSYONIC is a senior-level technical lead responsible for driving innovation within a high-priority medical device and robotics programs. This role bridges the gap between R&D prototyping and commercial-scale manufacturing. You will ensure that every engineering output-from a prosthetic finger to a complex database – is robust, clinically relevant, and compliant with global regulatory standards (FDA, ISO).

As a Level IV engineer, you are expected to not only execute technical deliverables but also mentor junior staff and lead major subsystems through the entire product lifecycle.

Core Responsibilities:

1. Product Development & Lifecycle Leadership

• Design Driver: Lead the design and development of Class I, II, and III medical devices, including advanced bionic prosthetics and robotic systems.

• Technical Feasibility: Spearhead system-level feasibility studies and Preliminary Hazard Analysis (PHA) to identify and mitigate risks early in the R&D phases.

• V&V Excellence: Lead Verification and Validation (V&V activities, including drafting test protocols, executing bench testing, and authoring formal technical reports.

2. Quality, Risk, and Regulatory Compliance

• Design Controls: Own assigned sections of the Design History File (DHF). Ensure all work aligned with ISO 13485 and ISO 14971 (Risk Management).

• Documentation: Maintain meticulous engineering notebooks and author pFMEA/dFMEA documents to ensure a clear requirement-to-test traceability matrix.

• Regulatory Support: Partner with the Regulatory team to provide technical data for FDA 510(k), De novo, or PMA submissions.

Functional Track Options:

• Mechanical (ME): Develop innovative geometries for additive, substrative and other MFG processes, including development of electromechanical assemblies using SolidWorks or CATIA. Manage CAD updates, BOMs, and sustaining engineering for existing prosthetic and Robotic systems.

• Electrical (EE): Design complex schematics and high-density PCBA layouts in Altium Designer. Oversee prototype fabrication and pilot runs with contract manufacturers

• SW-Embedded: Develop, test, and deploy firmware for low-power medical devices. Focus on real-time OS, power management, and sensor integration.

• SW-App/DB: Lead full-stack development for user interfaces and secure data management systems. Focus on clinician-facing tools and prosthetic tuning apps.

• Eng. Project Manager: Cross-functional coordination, timeline management, and ensuring technical milestones meet quality and regulatory "gate" requirements

General Requirements:

• Prototyping: "Hands-on" mindset. Ability to build and iterate on physical or digital prototypes to prove concepts quickly.

• Technical Analysis: Proficient in data analysis to evaluate performance against engineering specifications (e.g., using Minitab, Python, or R).

• Design Control: Assist in the creation of Design History Files (DHF), including risk assessments (pFMEA/dFMEA) and requirement traceability.

• Design Transfer: Act as a liaison to manufacturing, developing jigs, fixtures, and assembly processes to ensure a smooth transition from R&D to production.

• Vendor Management: Manage external suppliers for CNC, 3D printing (Metal/Polymer), and injection molding

• Affinity for Additive Design: Drive innovation, leveraging bespoke to mass production utilizing additive design as a core skillset.

Qualifications:

• Education: B.S. in Mechanical, Electrical, Biomedical Engineering, Computer Science, or Additive Manufacturing. Advanced degree (M.S./Ph.D.) preferred.

• Experience: 5–8 years in a highly regulated industry (Medical Device preferred, Aerospace or Automotive considered).

Compliance Knowledge: High-level understanding of FDA CFR 21 Part 820 and ISO 13485.

• Software Proficiency: Professional-grade mastery of relevant CAD/ECAD tools (SolidWorks, Altium, Creo, etc.) and standard office suites.

The ’PSYONIC’ Fit (Preferred Qualifications):

• Robotics Passion: Experience with bionic limbs, orthopedic implants, or complex robotic actuators.

• Advanced Toolsets: Experience with nTopography (nTop), MATLAB, Python, or Verilog/VHDL.

• 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.

Why PSYONIC?

At PSYONIC, we don't just build robots; we redefine human ability. We value innovation, empowerment, and commitment to excellence. You will work on the bleeding edge of bionics in a culture that prizes "doing" over "discussing."