Senior Process Development Engineer

Mesa Labs Career • Lakewood, CO

1d • Onsite

About The Position

The Senior Process Development Engineer is responsible for leading the development, optimization, and scale-up of manufacturing processes for a wide range of products. Drive process improvement initiatives, troubleshoot complex issues, and mentor junior engineers while collaborating with cross-functional teams. Leads projects to enhance production efficiency, improve product quality, and reduce costs, while ensuring that processes comply with regulatory standards and industry best practices. The Senior Process Development Engineer will also be involved in strategic decision-making related to process innovation and technology advancement.

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field.
• Minimum of 5 years of experience in process development, manufacturing engineering, or a related field, with a demonstrated ability to lead process improvement initiatives and projects.
• Advanced knowledge of process engineering principles (e.g., thermodynamics, material science, fluid dynamics, heat transfer).
• Expertise in process optimization tools and techniques, including Six Sigma, Design of Experiments (DOE), Statistical Process Control (SPC), and Failure Modes and Effects Analysis (FMEA).
• Strong understanding of regulatory requirements (e.g., GMP, FDA, ISO) and experience ensuring compliance in process development and manufacturing.
• Strong leadership skills with a proven ability to lead cross-functional teams and manage complex projects.
• Excellent communication skills, both written and verbal, with the ability to present complex technical concepts to senior management and external stakeholders.
• Ability to influence decision-making and drive results through technical expertise and collaboration.

Nice To Haves

• Familiarity with process simulation software (e.g., Aspen Plus, COMSOL) and data analysis tools (e.g., Minitab, MATLAB) is a plus.

Responsibilities

• Lead the design, optimization, and scaling of manufacturing processes, from initial concept through full-scale production.
• Develop and refine process flow diagrams (PFDs), process and instrumentation diagrams (P&IDs), Standard Operating Procedures (SOPs), and equipment specifications.
• Work with R&D and product development teams to translate product specifications and requirements into robust, scalable manufacturing processes.
• Spearhead the integration of new technologies, equipment, and automation solutions into existing manufacturing processes.
• Lead process improvement projects focused on enhancing yield, throughput, cycle time, and resource utilization.
• Use advanced statistical tools and methodologies (e.g., Six Sigma, DOE, FMEA, SPC) to identify inefficiencies, optimize process parameters, and solve complex manufacturing problems.
• Apply Lean Manufacturing principles to streamline processes, reduce waste, and improve cost-efficiency.
• Manage process benchmarking, performance tracking, and post-project evaluation to measure the impact of process improvements.
• Lead the troubleshooting and resolution of complex process-related issues during production and testing.
• Provide expert technical support to operations teams, guiding them through complex process challenges and ensuring timely resolution.
• Drive root cause analysis for non-conformances, process deviations, and product quality issues, implementing corrective actions and preventive measures.
• Collaborate with cross-functional teams (quality, production, supply chain, etc.) to identify and resolve process bottlenecks or inefficiencies that impact production schedules.
• Manage and lead cross-functional project teams to implement new manufacturing processes, product transitions, and process improvements.
• Act as the technical leader in the development and execution of process development projects, ensuring alignment with business objectives and timelines.
• Work closely with the production, quality, regulatory, and engineering teams to ensure that process designs meet safety, quality, compliance, and cost objectives.
• Develop and maintain strong relationships with external vendors, suppliers, and technology partners to support process development and procurement.
• Oversee the scale-up of new processes from laboratory or pilot-scale to full-scale manufacturing, ensuring process robustness and scalability.
• Coordinate process validation activities to ensure compliance with industry regulations (e.g., GMP, FDA, ISO) during process transfers.
• Lead technology transfer and process optimization initiatives to ensure smooth transitions from R&D to production while meeting cost, performance, and quality targets.
• Mentor and provide technical guidance to junior engineers, supporting their professional development and growth within the organization.
• Lead training sessions for the engineering and production teams on new process technologies, methodologies, and best practices.
• Foster a culture of innovation, continuous learning, and collaboration within the process development team.
• Prepare detailed technical reports, project plans, and presentations for senior management, summarizing project progress, challenges, and results.
• Ensure all process documentation is maintained in accordance with company standards, regulatory requirements, and quality systems (e.g., ISO, GMP).
• Lead the creation of process-related documentation for audits, regulatory submissions, and technical reviews.
• Contribute to the strategic direction of the process development function, identifying new opportunities for process innovation, cost savings, and technology advancement.
• Drive the adoption of new process technologies, tools, and automation techniques to support the company’s long-term manufacturing goals.
• Evaluate emerging industry trends and technological advancements, recommending their integration into the company’s manufacturing processes.

Benefits

• Competitive wages
• Potential bonus opportunities
• Equity awards
• Commission
• Tiered Medical, Dental and Vision Insurance options
• Health savings (HSA) accounts
• Healthcare & dependent care flexible spending (FSA) accounts
• Company paid short term and long-term disability (unless covered by a state disability plan)
• Company paid life insurance and AD&D
• Flexible Time Off Policy
• Paid sick leave of 48 hours per calendar year
• Four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws
• 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1
• Employee Wellness and Financial Assistance Resources through Cigna and NY Life
• Nine (9) paid company holidays per year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior