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