Manufacturing Engineer II

Planet Pharma; Boulder (CO); On-site; USD 55,104 - 64,747; Full time

Job summary

Planet Pharma is seeking a project-focused engineer to drive MDR projects across multiple product lines at our Boulder Plant. You will manage schedules, budgets, and capital initiatives while ensuring quality and regulatory compliance for life-saving medical devices.

You will apply manufacturing engineering expertise and financial acumen to deliver cost savings, capacity expansion, and run-the-business projects, collaborating with R&D, Quality, Operations, and external partners.

Qualifications

• Bachelor's degree in Engineering.
• 2 years’ experience or advanced degree.
• Experience in regulated environment (Medical Device preferred) and project management.

Responsibilities

• 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 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.

Skills

Project Management

Manufacturing engineering

Financial / Business Acumen

Education

Bachelor's degree in Engineering

Job description

Pay 40-47/h depending on experience

Top 3 technical skills that are required for the role:

1.Project Management

2.Manufacturing engineering experience in regulated environment (Medical Device preferred)

3.Financial / Business Acumen

Education Required: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

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

What is your timeline for scheduling interviews?ASAP

What 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.

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.