Project Engineer

Project Engineer

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!

Location: On-site in Fort Collins, CO

Schedule & Hours: Mon-Fri, 8:00am-4:00pm

Position Summary:

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.

Essential Duties & Responsibilities:

• 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 or coordinate clear protocols, engineering reports, trial summaries, capability analyses, and objective evidence suitable for controlled QMS records.
• Perform work in accordance with applicable ISO 13485 procedures, customer requirements, safety practices, and document-control expectations.

• Partner with Sales and Business Development during technical reviews and communicate feasible options, tradeoffs, costs, risks, and timing in customer-ready language.
• Work closely with Manufacturing, Quality, Supply Chain, Tooling, Finance, and Operations to confirm capacity, staffing, equipment, supplier, and launch readiness.
• Support intercompany tooling and manufacturing transfers through technical due diligence, readiness review, relocation planning, qualification, and production stabilization.
• Manage multiple concurrent quotations and programs while maintaining responsiveness, ownership, and accurate records.

Qualifications & Skills:

• Bachelor's degree in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical field; equivalent experience may be considered.
• Minimum of 3 years of experience in thermoplastic injection molding, tooling, technical estimating, project engineering, or regulated manufacturing; medical molding experience preferred.
• Demonstrated ability to interpret engineering drawings, geometric tolerances, material specifications, customer quality requirements, and mold concepts.
• Working knowledge of thermoplastic materials, mold construction, hot- and cold-runner systems, press selection, auxiliary equipment, automation, and secondary operations.
• Experience developing manufacturing cost estimates using material, machine, labor, tooling, validation, overhead, capacity, and risk assumptions.
• Experience leading cross-functional projects with suppliers and customers from quotation through production launch.
• Working knowledge of APQP principles, DOE, capability studies, steel-safe or tolerance-safe approaches, risk management, and process validation.
• Experience in ISO 13485 or another regulated Quality Management System preferred.
• Cost modeling, quote scope, supplier comparisons, NRE, capacity, lead time, assumptions, and margin awareness.
• Thermoplastic part design, tooling, materials, process concepts, validation needs, and secondary operations.
• Portfolio governance, schedules, budgets, stage gates, resources, risks, actions, change control, escalation, and launch readiness.
• Drawing review, measurement strategy, MSA, capability, DOE awareness, validation, root cause analysis, and technical reporting.
• Clear customer interaction, supplier management, cross-functional facilitation, negotiation, and executive-ready communication.
• Proficiency with Microsoft (Excel, PowerPoint, Word, etc.) and project scheduling tools; familiarity with CAD viewers, ERP, eQMS, and quoting systems preferred.

Work Environment & Physical Demands:

• Ability to sit, stand, and walk for extended periods throughout the day in the office, toolroom, metrology lab, and cleanroom.
• Ability to communicate verbally, hear clearly, and maintain corrected vision sufficient for reading, writing, reviewing detailed drawings, inspecting molded components, and using measurement tools.
• Physical agility to bend, kneel, reach, and perform hands-on program support, and verification activities.
• Precise hand-eye coordination for performing hands-on program support, dealing with small components, and documentation accurately.
• Ability to lift and/or move up to 40 lbs., with or without reasonable accommodation.
• Comfortable working in manufacturing environments with varying temperatures, noise levels, and exposure to industrial materials.
• Comfortable working in controlled cleanroom environments, adhering to personal protective equipment (PPE), safety, and ISO procedures.

Benefits:

• 401(K) Retirement Plan
• Profit Share Program

• Medical, Dental, Vision, Life & AD&D Insurance, Short Term Disability (STD), Long Term Disability (LTD), Supplemental Insurance Plans, and Employee Assistance Program (EAP)
• Sick Time, Vacation Time, Holiday Pay, Volunteer Time Off (VTO), and Bereavement

Drug Testing Policy:

Injectech is committed to maintaining a safe and productive workplace. As part of this commitment, all potential