Project Engineer, Quality Engineering

Injectech, LLC has been a trusted supplier of fluid-control components for over 20 years. Our current senior management team has been with Injectech since the very beginning, bringing extensive knowledge of the medical device industry to every project.

Our employees are important to us! We want the best for our employees, not just at work, but through all aspects of their life. That is why we offer comprehensive benefits including health insurance, a 401(k) plan with up to 6% company match, and access to free financial advice about retirement, debt, and any future financial needs from a licensed Financial Advisor.

We strongly believe that the only way for our company to be successful is to make sure our employees have healthcare, mental healthcare, retirement options and financial education available to them.

We work hard to create a culture that promotes open lines of communication, a flexible work-life balance, continuous improvement in every department, and a place where employees want to be every day. We strive to hire and retain the best people, because we know a company is only as good as its employees. We hope you will join our team as we continue to grow and improve!

This position will remain open until December 10th.

Location:

On-site in Fort Collins, CO

Schedule &

Hours:

Mon-Fri, 8:00am-4:00pm

The Project Engineer converts customer opportunities into technically sound, commercially complete quotations and then leads awarded programs through tooling, validation, launch, and manufacturing handoff. The role combines front-end estimating with hands-on projecting engineering for precision thermoplastic injection-molded fluid-management components and assembles in a regulated medical manufacturing environment.

• Review customer RFQs, 2D drawings, 3D models, specifications, annual volumes, quality requirements, and launch expectations for completeness.
• Assess part manufacturability, draft, shutoffs, side actions, undercuts, gating, ejection, wall sections, tolerances, resin selection, insert molding, over-molding, and secondary operations.
• Develop quote assumptions, for press tonnage, cavitation, cycle time, shot and runner weight, material usage, yield, labor, setup, inspection, packaging, assembly, automation, and purchased components.
• Prepare tooling, mold modification, hot-runner, fixture, gage, automation, validation, qualification, and other non-recurring engineering estimates.
• Solicit and evaluate supplier quotations; normalize scope, identify exclusions, challenge cost and schedule, and document the selected technical approach.
• Build unit-cost and capacity models, define minimum run quantities, and support margin and pricing reviews with Commercial and Operations.
• Document open questions, risks, exclusions, customer dependencies, lead times, and quote validity before approval and release.

• Lead awarded programs from customer purchase order through design review, tool build or transfer, sampling, qualification, customer approval, launch, and production handoff.
• Create and maintain project plans, milestone schedules, budgets, action registers, risk registers, decision logs, and concise customer and leadership status reports.
• Coordinate mold makers, resin suppliers, automation builders, metrology resources, outside processors, and internal manufacturing locations.
• Review and approve mold concepts and designs for construction, serviceability, cavity identification, process robustness, and alignment with quoted scope.
• Plan and lead DFM reviews, mold trials, scientific molding studies, design of experiments, capability studies, first article activities, and corrective actions.
• Manage scope changes, commercial impacts, technical deviations, schedule risks, and escalation paths through documented cross-functional decisions.
• Ensure a complete transfer package at launch, including released drawings, bills of material, routings, specifications, process settings, inspection plans, training needs, maintenance requirements, and lessons learned.

• Partner with Quality and Manufacturing to define risk-based validation and qualification scope, including FAI, MSA or Gage R&R, IQ, OQ, PR, capability, and functional testing as applicable.
• Support PFMEA, control plan, inspection planning, traceability, material certification, packaging, labeling, and change-control requirements.
• Prepare…