New Product Introduction Engineer ( (Maternity Leave Replacement)

About Scopio Labs

Scopio Labs is a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global – and every individual at Scopio Labs is part of a life-saving mission.

About our technology

Scopio has developed a digital imaging platform using novel computational photography and clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. Scopio Labs has secured FDA clearance for its Full-Field Peripheral Blood Smear Application, and Scopio technology is in commercial use at hospitals and labs in the US, Europe, and Israel.

What you’ll be doing

As NPI engineer (Maternity Leave Replacement), you will lead end-to-end turnkey projects and tech transfer from development to production, coordinating with R&D, production, QMS, and product teams to ensure on-time delivery of projects.

Your responsibilities will include:

• Establishing new production lines at contract manufacturing (CMO) sites
• Overseeing engineering, quality, and process at CMOs
• Developing an in-depth understanding of CMO manufacturing capabilities and limitations
• Developing tech transfer plans according to the R&D and manufacturing process
• Creating and managing product device master record (DMR) including bill of materials (BOM) and mechanical and electrical specifications
• Overseeing CMO development of jigs, fixtures, process validations, and production in-process controls
• Identifying project critical paths and bottlenecks and implementing risk management methodologies
• Defining and leading execution to ensure on-schedule delivery according to scope of work and budget

The ideal candidate will meet the following requirements:

• B.Sc. in mechanical, electrical, or materials engineering
• 3 + years of experience in leading complex, technology-intensive NPI projects
• Experience working with multi-level internal stakeholders as well as CMOs and other vendors
• Experience with industrial production technology
• Understanding of production, quality, and compliance standards specific to the medical device industry
• Independent, proactive, and responsive
• Strong engineering background with business and operations proficiency
• Prior experience in manufacturing, operations, and supply chain in the medical devices sector
• Ability to present technical information and effectively communicate across all levels of the organization
• Multi-tasking capability with a prioritized and organized working methodology
• Eye for details and effective decision-making skills
• Excellent written and oral communication skills, with fluency in English
• Ability to travel to support production lines and vendors when needed