Role summary The Engineering Manager leads RedDrop Dx's mechanical and product engineering team as we scale our capillary blood collection devices from development into high-volume production. You will own the engineering roadmap from concept through design transfer, ensuring every design is safe, manufacturable and compliant with ISO 13485 and FDA design controls. This is a hands-on leadership role. You will build and mentor the team, guide injection-molded part design and tooling, and partner closely with Quality, Regulatory, Operations and contract manufacturers. You report to the VP of R&D.

Location:

on-site Employment type: Full-time, exempt Key responsibilities Team leadership Lead, hire, mentor and develop a team of mechanical, product and manufacturing engineers. Set priorities, allocate resources and hold the team to schedule, budget and quality commitments. Build a culture of rigor, ownership and clear documentation. Product development and design controls Direct device development from concept through verification, validation and design transfer under 21 CFR 820 and

ISO 13485.

Own design inputs, outputs, design reviews, traceability and the Design History File (DHF). Lead risk management activities per ISO 14971, including dFMEA, pFMEA and hazard analysis. Drive design verification testing and support usability and clinical evaluations. Plastics and molded part design Guide the design of precision injection-molded components, including DFM/DFA, tolerance analysis, GD&T and material selection for medical-grade polymers.

Lead tooling programs with molders:

mold flow reviews, tool kickoffs, T0/T1 sampling and first article inspection. Resolve molding and assembly issues such as warp, sink, flash, short shots and dimensional variation. High-volume manufacturing Scale products from pilot builds to high-volume production, including multi-cavity tooling and automated assembly. Lead process validation (IQ/OQ/PQ) and work with contract manufacturers and suppliers to reach yield, cost and capacity targets. Support sustaining engineering, design changes and CAPA investigations through the change control process. Cross-functional partnership Work with Quality and Regulatory on submissions, audits and QMS compliance. Partner with Operations, Supply Chain and leadership on product roadmap, COGS and launch planning. Required qualifications B.S. in Mechanical, Biomedical or Plastics Engineering, or a related field. 8+ years of medical device product development, including 3+ years leading engineering teams. Hands-on experience working in an

ISO 13485

quality system and with FDA design controls (21 CFR 820). Proven record taking at least one medical device from concept through design transfer to commercial production. Deep experience designing injection-molded plastic parts, including DFM, GD&T, tolerance stack-ups and tooling development with molders. Experience scaling products to high-volume manufacturing (hundreds of thousands to millions of units per year), including process validation. Working knowledge of

ISO 14971

risk management. Proficiency in 3D CAD (SolidWorks or equivalent). Clear written and verbal communication, and comfort presenting to executives, auditors and partners. Preferred qualifications M.S. in an engineering discipline. Experience with blood collection, diagnostics, drug delivery or other single-use, disposable devices. Familiarity with microfluidics, wearables or skin-interfacing devices. Experience with multi-cavity tooling, overmolding, ultrasonic welding, adhesive bonding and automated assembly lines. Background supporting FDA 510(k) or De Novo submissions and EU MDR technical documentation.

Statistical methods for manufacturing:

DOE, process capability (Cpk), SPC and Six Sigma. Experience managing offshore or domestic contract manufacturers. Startup experience and comfort with ambiguity and rapid growth.

Pay:

$125,000.00 - $170,000.00 per year

Benefits:

Paid time off

Work Location:

In person