Principle Systems Engineer

About Muscle Metrix LLC (sister company of Bionic Skins LLC):

We are an early-stage medical device startup that is ushering in a new generation of bionic devices that connect to the peripheral nervous system. Our mission is to restore intuitive control and function to individuals with limb pathology.

We are developing a novel, neuromechanical controller (NMC) platform that uses sensor fusion to interpret mechanoneural signals and control robotic limbs in real-time. Here, magnets are implanted in the antagonist muscles preserved within the amputated limb. Magnetometer arrays within the NMC wirelessly image the magnetic fields from these process the time-varying magnetic fields corresponding to the antagonist muscle contraction and in accordance project those contractions onto the control of the powered prosthesis joint.

As our Systems Engineering Lead, you will be the champion for product safety, reliability, and regulatory compliance; will drive final packaging design and execution; and will manage contract manufacturing execution, including building a high-coverage production framework—with the rigor required for an FDA Class II medical device.

This role requires a systems-level perspective and a deep understanding of the nuances of embedded medical systems and instrumentation; you must be comfortable operating at the nexus of hardware, firmware, and software. You will be responsible for creating and executing the master plan that proves our device is safe, effective, and ready for regulatory submission.

Please note: this position is only open to candidates within the Boston area, or who plan to immediately relocate here. We are not currently accepting candidates need visa sponsorship now or in the future.

• Product packaging design and execution:
  Build the design requirements database within a Quality Function Deployment (QFD) context and use this as the basis to drive the generative design, V&V test execution, contract manufacturing, and test engineering flow that delivers a customized conformal NMC that connects the peripheral nervous system of the Wearer to the powered prosthesis
• Build the Risk Management process in compliance with ISO 14971:
  Conduct formal hazard analysis and identify risk control measures (RCM) needed to enable safe and effective use of the NMC platform as integrated with the powered prosthesis. Drive execution of the RCM, including modeling risk via fault-tree analysis and implementing the RCM into the NMC design. Author the Risk Management Report—summarizing the process, risk/benefit tradeoffs, and the design/test artifacts that serve as evidence of ISO 14971 compliance.
• V&V Strategy & Architecture:
  Architect and lead the development of the entire V&V strategy. Build a Measurement Systems Analysis process framework and tools for test fixture design that delivers verifiable test fixture repeatability and reproducibility. Plan and author thorough verification and validation test plans, protocols, and reports that achieves high-coverage testing of N all phases of product delivery—including surgical execution; product design; contract manufacturing;
  
  and final fitting, tuning and powered prosthesis integration. Use Highly-Accelerated Life Testing (HALT) as the basis for our test-to-failure framework.
• Forensic Debugging & Systems Testing:
  Design, build, and execute hands‑on tests for our complex embedded medical system. Go beyond pass/fail; lead root‑cause analysis and forensic debugging for complex multidisciplinary failures (firmware, electrical, mechanical). Build the process framework, and ensure compliance with a formal Eight Disciplines (8D) Problem Solving Process.
• EMC & Electrical Safety Ownership:
  Lead the definition and execution of electrical safety and electromagnetic compatibility testing (e.g., IEC 60601‑1 & IEC 60601‑1‑2), ensuring our sensor‑fusion platform performs reliably in noisy environments.
• Standards & Compliance:
  Apply your understanding of medical device standards (e.g., IEC 62304, ISO 13485) to define test requirements and ensure our design outputs meet our design inputs.
• Cross‑Functional Contribution:
  Leverage your…