Surgical Development and Human Factors Lead

black.ai; San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

On-site meals

Healthcare, dental and vision

Pension matching/401k

PTO

Professional development

Flexible working hours

Travel opportunities

Job summary

Coherence Neuro seeks a Surgical Development and Human Factors Lead to own the end-to-end surgical workflow for their implantable device. You will guide implantation, connection, fixation, closure, programming, troubleshooting, and explant/revision through cadaver and anatomical-model studies with surgeons.

You will translate observations into user needs and design inputs, collaborating with Product Development, Regulatory, and Quality to ensure traceability and safe, effective devices.

Qualifications

• Bachelor's or advanced degree in related field; formal human-factors training preferred.
• 5+ years in surgical device development with surgeons.
• Experience planning cadaver laboratories and anatomical-model studies.
• Strong skills in user-needs elicitation, context inquiry, and risk traceability.
• Familiarity with IEC 62366-1 and FDA Human Factors guidance.
• Ability to elicit unbiased workflow in the OR without leading participants.

Responsibilities

• Own development of the end-to-end surgical workflow for implantation, connection, fixation, closure, programming, troubleshooting, and explant/revision.
• Plan and run structured work with surgeons in cadavers and anatomical models to observe behavior and test concepts.
• Translate observations into documented user needs, workflow requirements, and training assumptions.
• Use contextual inquiry, task analysis, and formative usability methods to distinguish surgeon preference from broad needs.
• Partner with Product Development, Systems, and Mechanical Engineering on access, anatomy, and instrumentation.
• Collaborate with Regulatory and Quality to ensure traceability in HF and risk-management files.
• Establish a diverse surgeon panel and manage conflicts to avoid bias in findings.
• Maintain controlled cadaver-study plans, records, and biosafety and facility compliance.

Skills

Biomedical engineering

Human factors

Industrial design

Clinical science

Human factors training

Education

Bachelor's or advanced degree in Biomedical Engineering / Human Factors / Industrial Design / Clinical Science

Job description

Job Title: Surgical Development and Human Factors Lead

Location: San Francisco, CA or Cambridge, United Kingdom

Type: Full-Time (on-site)

Coherence Neuro is a highly interdisciplinary neurotechnology company solving some of the most challenging biological and medical problems that remain unmet. Our goal is to develop technologies that significantly increase the quality and length of life for those with debilitating and deadly cancers in the brain and body. We are backed by the best global venture capital firms, and are scaling our team across multiple sites to bring our products to those who need it as quickly and safely as possible. If you're driven to push the boundaries of engineering and science and want to help build something that genuinely changes lives, we want to hear from you. We value diversity and encourage applicants from all backgrounds to join us in our mission. Learn about our team here!

We are building the surgical and human-factors foundation for our implantable systems and are looking for a detail-orientated and hands-on Surgical Development and Human Factors Lead to own it. This person will play a central role in developing the end-to-end surgical workflow for our device - implantation, connection, fixation, closure, programming, troubleshooting, and explant/revision - through structured cadaver and anatomical-model studies with surgeons. Following each study, this position will translate real procedural behavior into documented user needs, design inputs, use-related risk controls, and training assumptions that carry through our human-factors engineering file. This is an ideal role for someone who enjoys working hands-on in the operating room and cadaver lab, and who thrives building rigorous, traceable systems from the ground up in a fast-paced startup environment. The position will work closely with our Product Development, Systems and Mechanical Engineering, Regulatory Affairs, and Quality teams.

Key Responsibilities

• Own development of the end-to-end surgical workflow for implantation, connection, fixation, closure, programming, troubleshooting, and explant/revision.
• Plan and run structured work with surgeons in cadavers and anatomical models to observe real behavior, identify unmet needs, and test procedural concepts, instruments, and device iterations.
• Translate observations into documented user needs, workflow requirements, critical tasks, use-related risks, design inputs, acceptance criteria, and training assumptions.
• Use contextual inquiry, task analysis, and formative usability methods to distinguish a surgeon preference from a broadly applicable user need or safety requirement.
• Partner with Product Development, Systems, and Mechanical Engineering on access, anatomy, ergonomics, instrumentation, implant positioning, fixation, and failure-recovery trade-offs.
• Partner with Regulatory and Quality so cadaver and simulated-use learning is traceable within the human-factors engineering and risk-management files; ensure exploratory and developmental testing never substitutes for the validation process.
• Establish a diverse surgeon panel, manage conflicts and minority views, and ensure advisor compensation never influences design findings or future clinical relationships.
• Maintain controlled cadaver-study plans, observation guides, recordings/notes, findings, decisions, and traceability; oversee appropriate sourcing, consent, biosafety, and facility requirements.

Required Qualifications and Skills

• Bachelor's or advanced degree in biomedical engineering, human factors, industrial design, clinical science, or a related field; formal human-factors training strongly preferred.
• 5+ years in surgical device development, clinical engineering, human factors, or procedural innovation, with direct experience developing an implantable or interventional device with surgeons.
• Demonstrated experience planning and facilitating cadaver laboratories, anatomical-model studies, and formative usability work that changed product or instrument design.
• Strong command of user-needs elicitation, contextual inquiry, task analysis, use-related risk analysis, and traceability into design inputs; familiarity with IEC 62366-1 and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices.
• Credibility in the operating-room environment and the ability to elicit rationale without leading participants or letting a single influential surgeon define the workflow.
• Hands-on, low-ego orientation - comfortable setting up labs, handling prototypes, observing difficult procedures, and converting conflicting feedback into testable questions.

Bonus Skills

• Prior experience developing surgical workflow, instrumentation, or training materials for a first-in-human or early clinical program.
• Familiarity with human-factors or design-control software and documentation systems.
• Formal training or certification in human factors engineering or usability engineering.
• Prior experience in an early-stage medtech or neurotech startup is a huge plus.

Reporting Structure:

This role is an integral part of the Translational Research team and reports directly to the Director of Clinical Translation.

Benefits:

• Competitive salary and share options.
• Daily meals provided and snacks provided on site.
• Healthcare, dental and vision (CA location)
• Pension matching (UK)/401k with company match (CA location)
• Industry leading paid time off (PTO)
• Professional development support and training opportunities.
• Flexible working hours and travel opportunities (We have sites in Australia, UK and US!).
• A chance to work on impactful, life-changing technologies in a dynamic, innovative environment.