Manufacturing Engineer II

Reference: 628381Posted: 2026-08-25Location: Boulder, COCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on us.fitly.work 40-47/h depending on experienceTop 3 technical skills that are required for the role:1. Project Management2. Manufacturing engineering experience in regulated environment (Medical Device preferred)3. Financial / Business AcumenEducation Required: Bachelors degree in EngineeringYears’ Experience Required: 2 years or advanced degree.Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours / week 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 PlantWhat is your timeline for scheduling interviews? ASAPWhat product line will this person support? This person will support the MDR projects across all product lines, as well as other projects (including capital) as time permits. 8/25 updated responsibilities from HM:Responsibilities may include the following and other duties may be assigned.Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. 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 SOP’s 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.