Future Forward – Clinical Research Engineering Lead

Future Forward – Clinical Research Engineering Lead

Requirements

• Advanced degree (MS or PhD preferred) in Biomedical Engineering, Mechanical Engineering, or a related technical discipline with direct application to medical device design and clinical integration.
• Minimum 10+ years of hands-on experience in medical device development, with at least 5+ years in clinical engineering leadership roles overseeing cross-functional teams through all phases of product development—concept, preclinical, first-in-human (FIH), early feasibility and traditional clinical studies.
• Proven track record of leading complex, multi-site preclinical and clinical studies, including protocol design, regulatory strategy interface, and real-time clinical decision support.
• Demonstrated expertise in translating unmet clinical needs into engineering requirements, including authorship of product requirement documents (PRDs), clinical risk analyses (CRA), usability risk assessments (URA), and design input documentation.
• Strong technical knowledge in areas including robotic systems, surgical instrumentation, embedded software interaction, and procedural workflows in minimally invasive surgery or interventional therapeutics.
• Deep familiarity with design control processes FDA QSR or MDR compliance.
• Expert-level ability in clinical risk identification and mitigation, including development and execution of validation strategies to de-risk usability and safety for novel technologies.
• Skilled in project planning and execution using tools such as Microsoft Project, Smartsheet, or equivalent; demonstrated ability to model resource requirements, develop multi-phase program timelines, and manage cross-functional interdependencies.
• Demonstrated leadership in clinical lab and benchtop model development, including mechanical test method design and prototype evaluation aligned with defined performance specifications.
• Experienced in working directly with surgeons, key opinion leaders (KOLs), and multidisciplinary experts to gather, synthesize, and apply clinical feedback to early-stage technology development.
• Strong working knowledge of intellectual property development and a history of contributing to patent filings related to clinical applications, device design, or procedural innovation.
• Excellent written and verbal communication skills, capable of clearly articulating complex clinical and technical information across stakeholders including regulatory, engineering, and commercial leadership.
• Proven ability to lead, coach, and develop high-performance teams; demonstrated success recruiting and retaining top clinical engineering talent.
• Must be available to work full-time and commute/relocate to Sunnyvale, CA.
• Up to 25% travel. Some international travel may be required.

Responsibilities

• Serve as the primary clinical engineering leader for early-stage robotic platform development within Future Forward.
• Establish and oversee clinical development strategies for preclinical and clinical evaluation phases, ensuring alignment with regulatory, reimbursement and commercial goals.
• Define and manage program goals, timelines, and budgets across multiple, concurrent projects with varying complexity and risk levels.
• Drive alignment between engineering, clinical, regulatory, and commercial functions through effective communication and clear prioritization frameworks.
• Develop and manage integrated program plans, Gantt timelines, resource loading, and cross-functional dependencies.
• Optimize allocation of clinical engineering talent, labs, and capital resources across multiple projects.
• Own clinical engineering budget forecasting and ensure disciplined use of company resources aligned with portfolio objectives.
• Ensure all programs are progressing according to plan, managing risks, resolving blockers, and adjusting resources as needed.
• Lead, mentor, and grow a team of clinical research engineers, focusing on both individual development and organizational capability.
• Foster a high-performance, values-driven culture focused on accountability, transparency, and innovation.
• Anticipate organizational capability needs and proactively recruit or develop team members to meet existing and evolving business demands.
• Lead development of novel evaluation models, procedural workflows, and experimental designs to accelerate technology iteration and maturity.
• Oversee prototype evaluation activities in clinical labs, ensuring clear translation of insights to design and systems engineering teams (both qualitative and quantitative).
• Guide the creation of clinical risk assessments and clinical validation strategies to support design iteration and regulatory filings.
• Serve as a primary clinical voice in early-stage programs, influencing cross-functional peers and senior leaders.
• Engage with KOLs, surgeons, and external experts to pressure-test clinical use cases and inform platform direction.
• Collaborate with regulatory, reimbursement, and product management teams to shape evidence generation plans.
• Lead clinical strategy and execution of preclinical studies and early feasibility trials to de-risk new platforms.
• Lead clinical engineering team through support of clinical studies including larger scale studies such as support of qualified registries and randomized controlled trials.
• Drive protocol design, site selection, IRB engagement, and real-time response to study execution challenges.
• Support eventual scale-up and transition to clinical affairs for pivotal studies and commercial readiness.

Preferred Qualifications

No preferred qualifications provided.