This position will remain open until filled.
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:
Technical Estimating & RFQ Development
- 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.
Project Engineering & Program Execution
- 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.
Quality, Validation, & Regulatory Support
- 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.
Cross-functional & Customer Support
- 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 priniciples, 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 employees must pass a drug screening as a condition of employment. The drug test is a 5-panel screening and must be completed to your start date.
