Manufacturing Engineer II

Pay: 40-50/h depending on experience.

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

Bachelors degree in Engineering

Years Experience

Required:

2 years or advanced degree.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours / week (Full time onsite at the Boulder Plant.)

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite, full time at the Boulder Plant.

In this role, you will support 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. 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 need to 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.
• 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.