Senior Quality & Project Engineer

Job Description

Job Description

Senior Quality & Project Engineer

Dublin, OH – Onsite / Hybrid (Local Candidates Preferred)

Full-Time | Medical Device | Robotics + Clinical Innovation

We are developing a breakthrough robotic medical device designed to improve patient outcomes and transform how clinicians deliver care. We are seeking a Senior Quality & Project Engineer to build and own our quality system while driving cross-functional project execution across engineering, clinical, and regulatory workstreams.

This is a high-impact, hybrid role blending Quality Engineering and Project Management , ideal for someone who thrives in fast-paced early-stage environments, is energized by ownership, and wants to help bring a first-of-its-kind device to market.

What You’ll Do

Quality Engineering (Primary Long-Term Focus)

• Lead the development, implementation, and ongoing management of an electronic Quality Management System (eQMS)
• Ensure compliance with ISO 13485, current FDA regulations and guidance, and conformity to relevant recognized standards such as IEC 62304 and IEC 62366-1
• Maintain core QMS elements including DHF, DMR/DHR, CAPA, Risk Management Files, document control, and change control
• Evaluate the current QMS platform and lead migration to an industry-recognized eQMS if appropriate
• Partner closely with clinical leadership to support readiness for upcoming testing, verification/validation, and future clinical trials
• Serve as the internal SME for quality requirements and help the team interpret standards as the device evolves
• Support internal audits and manage relationships with external quality consultants as needed

Project Management (Majority initially; transitions to minority over time)

• Establish and maintain the single integrated project schedule (“schedule of truth”) across engineering, clinical, quality, and regulatory teams
• Run recurring milestone meetings, ensuring dependencies, risks, and timelines are clear and aligned
• Coordinate cross-functional execution, driving follow-through, documentation readiness, and timely decision-making
• Interface with Jira (reading tickets, understanding software timelines, logging issues) and integrate software progress into broader project planning
• Apply structured PM methodologies (Six Sigma, Lean, PMP, or similar) to improve visibility, reduce slippage, and increase operational consistency

What You Bring

Required Qualifications

• 5+ years of experience in medical devices, including 3+ years directly in Quality Engineering
• Direct experience with ISO 13485–aligned QMS implementation, ownership, or maintenance
• Ability to understand, interpret, and apply FDA regulations and relevant recognized standards, including:
• IEC 62304 – medical device software lifecycle processes
• IEC 62366-1 – usability engineering
• Experience supporting products through prototype → product development → regulatory readiness
• Strong documentation, communication, and cross-functional coordination skills
• Demonstrated ability to thrive in fast-moving, ambiguous early-stage environments

Preferred Qualifications

• Experience migrating or configuring medical-grade eQMS platforms (e.g., Greenlight, Enzyme, Qualio, MasterControl)
• Familiarity with robotics, embedded systems, or software-heavy medical devices
• Experience with Jira, MS Project, Smartsheet, or similar tools
• Six Sigma Green Belt or Black Belt, PMP, or equivalent PM certification
• Prior startup or small-team engineering experience

Who You Are

• A builder who enjoys creating systems, structure, and process from the ground up
• Equally comfortable with big-picture planning and detailed execution
• A low-ego contributor who thrives in small, high-collaboration environments
• Adaptable, curious, and energized by solving meaningful, messy problems
• Motivated by mission-driven work and excited to bring a novel medical device to market

Work Environment & Benefits

• Onsite required at the Dublin, OH facility, Hybrid may be considered for local candidates (2–3 days onsite weekly minimum)
• Equity: Stock options
• Benefits: Medical, dental, vision, flexible PTO, paid holidays, winter shutdown
• Relocation support available for candidates moving to the Columbus/Dublin region