Lead Project Engineer (Contract)

About EmitBio

EmitBio™ is a biotechnology company comprised of light and life scientists focused on the highly specific use of light to stimulate physiological signals and initiate healing at the cellular level. The company is advancing a proprietary technology platform to enable prophylactic and therapeutic treatments designed for high-volume deployment, with the goal of redefining the standard of care across multiple diseases and conditions.

We are seeking a Lead Project Engineer to join our team developing novel light-based medical technologies. This role is ideal for a highly hands-on engineer who thrives in fast-paced environments and takes ownership of complex technical challenges from concept through commercialization.

The ideal candidate is a self-directed problem solver who can quickly understand, diagnose, and resolve multidisciplinary engineering challenges while driving measurable progress across teams and partners.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or assume responsibility for on-going sponsorship of an employment Visa at this time.

Key Responsibilities:

• End-to-End Hardware Integration: Drive selection, validation, and implementation of solutions for handheld clinical devices, ensuring all mechanical and electrical performance requirements are met.
• Software Lifecycle Management: Serve as the primary technical liaison with contract software developers; oversee code updates, verify deliverables, and maintain compliance with IEC 62304.
• Technical Documentation & Compliance: Independently update design specifications, risk management files, and design history documentation within the eDMS with minimal QA oversight.
• Manufacturing & Logistics Coordination: Act as the main point of contact with the Contract Manufacturer (CM), overseeing equipment transfer, materials logistics, and process readiness for manufacturing scale-up.
• Verification & Clinical Readiness: Perform hands-on bench testing, support device labeling, and prepare final kits to ensure readiness for clinical study deployment.
• Quality & Compliance: Adhere to and ensure compliance with EmitBio’s quality system

Required Skills & Qualifications:

• Experience: Minimum of 10 years in multi-disciplinary engineering roles (Electrical, Mechanical, or Systems), specifically within the Medical Device industry.
• Regulatory Fluency: Proven experience working under ISO 13485; ability to revise IEC 62304 software documentation and update Risk Management files (ISO 14971) with minimal supervision.
• Self-Directed Execution: Highly proactive and able to prioritize effectively with minimal supervision.
• Adaptive Problem Solving: Hands-on engineer with strong mechanical aptitude and the ability to adapt quickly in evolving environments.
• Operational Discipline: Proven ability to manage multiple complex workstreams—from lab testing to contract manufacturing—while maintaining attention to detail.

Desired Skills and Qualifications:

• Interpersonal Excellence: Strong communicator capable of effectively working with external partners, including contract manufacturers and software teams.
• Logistics Management: Experience coordinating equipment calibration and domestic shipping
• Documentation Systems: Proficiency with electronic Document Management Systems (eDMS) and formal Change Control processes.
• CAD Proficiency: Advanced understanding of SolidWorks 3D CAD and SolidWorks Product Data Management (PDM)
• Measurement: Practical experience with precision measurement tools and structured data collection methods

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the key duties and responsibilities.

Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing), and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours. Some travel may be required (5-10%).

EmitBio maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

EmitBio is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.