Manufacturing Engineer II - Exempt

Join our team in Boulder, CO, a vibrant city known for its stunning natural beauty and innovative spirit. In this role, you will be a crucial part of the PMO operations engineering team, driving projects and capital initiatives to run the business and deliver cost savings, while complying with quality and regulatory policies for components used in life-saving medical devices.

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design the arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Design sequences of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapt machine or equipment design to factory and production conditions.
• Incorporate inspection and test requirements into the production plan as necessary.
• Inspect the performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action of problems and deficiencies to ensure product quality.
• Develop manufacturing processes applicable to statistical process control and may develop those techniques.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure processes and procedures comply with regulations.

Key Technical Skills Required

• Project Management
• Manufacturing engineering experience in a regulated environment (Medical Device preferred)
• Financial / Business Acumen

Qualifications

• Bachelor's degree in Engineering
• Minimum of 2 years of relevant experience or an advanced degree
• Full-time onsite position at the Boulder Plant, 40 hours per week

Role Overview

You will apply financial acumen and manufacturing engineering expertise to drive projects to completion, relying on influence, resilience, and strong cross-functional collaboration. You will work closely with R&D, Quality, Operations, Supply Chain, and external partners to ensure robust, compliant, and scalable manufacturing solutions.

• Manage specific individual MDR project schedules and lead cross-functional teams on engineering and capital projects to launch new artwork and labeling, drive continuous improvements, and keep the business running.
• Manage finances associated with projects, including spend forecast accuracy, drafting POs, capitalization, and tracking capital project budgets.
• Create and own cost savings, capacity expansion, and run-the-business projects, from initial proposals through implementation and project completion.
• Execute process and equipment validations through Installation Qualification, Operational Qualification, and Process Qualification (IQ, OQ, PQ) using statistical analysis tools.
• Provide process engineering support for production problems, engineering runs, and equipment or process troubleshooting.
• Author and institute written technical specifications and SOPs through the document control system for new and existing processes and equipment.
• Drive continuous improvement initiatives focused on yield, efficiency, quality, and cost.
• Collaborate with suppliers and contract manufacturers to support equipment implementation, process improvements, and technical alignment.