Senior Manufacturing Engineer

Position Overview

We are seeking two contract Manufacturing Engineers (one mid-level, one senior-level) to support our PMO Operations Engineering team at the Boulder plant. In this role, you will drive engineering projects and capital initiatives to sustain business operations, deliver cost savings, and ensure strict compliance with quality and regulatory policies for components used in life-saving medical devices.

These positions require a blend of financial acumen, manufacturing engineering expertise, and strong cross-functional collaboration. You will partner closely with R&D, Quality, Operations, Supply Chain, and external partners to deliver robust, compliant, and scalable manufacturing solutions.

Core Responsibilities (Both Roles)

• Project & Financial Management: Manage project schedules, track capital project budgets, draft purchase orders (POs), and maintain accurate spend forecasting.
• Validation & Testing: Execute process and equipment validations through Installation Qualification, Operational Qualification, and Process Qualification (IQ/OQ/PQ) using statistical analysis tools.
• Operational Support: Provide process engineering support for production disruptions, engineering runs, and equipment/process troubleshooting.
• Documentation: Author and institute written technical specifications and Standard Operating Procedures (SOPs) through the document control system.
• Continuous Improvement: Lead initiatives focused on optimizing yield, efficiency, quality, and cost reductions.
• Supplier Collaboration: Work with external suppliers and contract manufacturers to support equipment implementation and technical alignment.

Role Variations & Level Requirements

1. Manufacturing Engineer II

• Pay Rate: $38.00 - $50.00 / hour
• Scope & Autonomy: Acts as an established individual contributor. Works independently under general supervision on larger, moderately complex projects. Focuses heavily on managing specific individual Medical Device Regulation (MDR) project schedules and launching new artwork and labeling.
• Experience: Minimum of 2 years of relevant experience with a Bachelor’s degree, or an Advanced Degree with 0 years of experience.

2. Senior Manufacturing Engineer

• Pay Rate: $50.00 - $70.00 / hour
• Scope & Autonomy: Acts as a seasoned individual contributor. Works independently under limited supervision to determine and develop approaches to solutions. Focuses on capital equipment planning, procurement, installation, commissioning, and integration across all product families at the Boulder plant.
• Leadership & Complexity: Reviews the work of lower-level specialists, delegates project tasks, and provides technical guidance and mentorship. Handles difficult, multi-faceted engineering issues and interfaces with senior internal and external customers.
• Experience: Minimum of 4 years of relevant experience with a Bachelor’s degree, or an Advanced Degree with a minimum of 2 years of relevant experience.

Required Knowledge and Skills

• Education: Bachelor’s degree in Engineering required.
• Project Management: Demonstrated ability to manage projects from initial design and proposal through to implementation.
• Regulated Industry Experience: Practical knowledge and competence within a regulated manufacturing environment (Medical Device preferred).
• Financial Acumen: Understanding of project capitalization, budget tracking, and financial forecasting.