Engineering Manager

Role details

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