Senior Manufacturing Process Engineer

Solmetex Inc•Colorado Springs, CO

1d•Onsite

About The Position

Manufacturing Engineer with strong process engineering and project management capability to drive manufacturing excellence, product scalability, and operational efficiency. This role emphasizes Lean principles, process optimization, and disciplined execution across the full product lifecycle—from design transfer through sustained production—while leading cross-functional teams to deliver results.

Requirements

Bachelor’s degree in mechanical engineering or related field
7–12 years of manufacturing engineering experience
Medical device or regulated industry experience
Lean Six Sigma certification
Experience with ERP systems (e.g., Microsoft Dynamics 365)
Experience with automation and equipment integration
Familiarity with Factory Physics concepts (flow, WIP, constraint management)
Process design/optimization (assembly, automation, packaging)
Design for Manufacturability (DFM), Design for Assembly (DFA), Geometric Dimensioning & Tolerancing (GD&T), tolerance analysis, material selection
CAD (SolidWorks or similar); tooling/fixture design
Validation (IQ/OQ/PQ) and test method development
Design of Experiment and basic statistical analysis
Lean tools (VSM, Kaizen, 5S, standard work)
Statistical Process Control (SPC), Process Capability (Cp), Process Capability Index (Cpk)
Line balancing, capacity/constraint management
Root cause analysis (5 Whys, Fishbone), PFMEA
CAPA and risk management
Project/program management (scope, schedule, risk)
Cross-functional leadership and stakeholder alignment
ERP/MRP (e.g., D365)
Data analysis tools (Excel, Minitab)
Strong documentation and change control discipline

Nice To Haves

PMP certification or equivalent experience preferred
Experience in regulated/QMS environments preferred

Responsibilities

Design, develop, and optimize manufacturing processes (assembly, automation, packaging)
Lead Lean initiatives (waste reduction, flow improvement, standard work, visual management)
Apply tools such as Value Stream Mapping (VSM), Kaizen, 5S, and root cause analysis
Improve throughput, reduce cycle time, and stabilize processes (SPC, Cp/Cpk)
Own process validation activities (IQ/OQ/PQ) and ongoing process capability monitoring
Lead cross-functional projects/programs tied to process improvements, NPI, and capacity expansion
Develop and manage detailed project plans (scope, schedule, cost, risks)
Drive execution against milestones with clear accountability and communication
Manage change control (ECR/ECO) and ensure alignment with quality and regulatory requirements
Lead and influence teams across R&D, Quality, Operations, Supply Chain, and Commercial functions
Align stakeholders on priorities, trade-offs, and execution plans without direct authority
Facilitate structured decision-making and ensure clear ownership of actions and deliverables
Drive accountability and maintain momentum across multiple concurrent initiatives
Partner with Operations to ensure efficient production flow and constraint management
Support capacity planning, line balancing, and labor optimization
Implement pull systems, WIP controls, and inventory optimization strategies
Collaborate with Supply Chain on supplier performance and material flow
Provide early input into product design to ensure manufacturability and scalability
Drive design improvements that reduce cost, complexity, and variability
Support transition from R&D to production (NPI, pilot builds, ramp-up)