Senior Manufacturing Engineer

Hydrogen Group; Draper (UT); On-site; USD 120,000 - 180,000; Full time

Job summary

Hydrogen Group is seeking a Senior Manufacturing Engineer to lead advanced engineering in a highly regulated medical device environment. This role focuses on improving yield, capacity, process robustness, and implementing new products, equipment, and technologies on second shift.

The position requires independent ownership, strong engineering judgment, and collaboration with Operations, Quality, Supply Chain, and Maintenance to deliver measurable improvements while ensuring safety and regulatory

Qualifications

• Bachelor's Degree in Engineering or a scientific field with 4+ years of industry or combined industry/education experience.
• Master's Degree or equivalent in Engineering or a scientific field with 3+ years of industry or combined industry/education experience.
• Ph.D. or equivalent in Engineering or a scientific field with relevant industry or combined industry/education experience.
• Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
• Knowledge of applicable FDA regulations and quality system requirements.

Responsibilities

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability, capacity expansion, cost reduction, and operational risk mitigation.
• Identify, prioritize, and implement process optimization opportunities using structured problem-solving methodologies, Lean Manufacturing, and continuous improvement principles.
• Serve as a technical leader and subject matter expert for manufacturing processes, equipment, and associated technologies.
• Partner with Operations, Quality, Supply Chain, Maintenance, and other cross-functional teams to improve manufacturing performance and achieve business objectives.
• Lead investigations and resolution of complex manufacturing, quality, and compliance issues, including CAPAs, nonconformances, audit observations, process deviations, and customer-impacting events.
• Apply statistical techniques and data-driven decision-making to evaluate process performance, identify root causes, and implement effective corrective and preventive actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a manufacturing technical expert.
• Design and execute engineering studies, experiments, process validations, and equipment qualifications.
• Develop and execute protocols, analyze results, prepare technical reports, and recommend implementation strategies based on data and risk assessment.
• Support the introduction and integration of new products, equipment, manufacturing technologies, and process improvements while ensuring compliance, manufacturability, and operational readiness.
• Ensure manufacturing equipment, tooling, fixtures, and processes meet applicable safety, quality, performance, and regulatory requirements.
• Lead cross-functional projects from concept through implementation using project management tools, risk assessments, and structured execution plans.
• Influence engineers, technicians, operations personnel, and business partners to achieve project objectives without direct authority.
• Mentor engineers and technicians in engineering best practices, manufacturing process control, data analysis, and structured problem solving.
• Provide technical direction and training to technicians supporting manufacturing operations and engineering studies.
• Develop and maintain manufacturing documentation, work instructions, procedures, training materials, and engineering records.

Skills

Independent work

Engineering judgment

Education

Bachelor's Degree in Engineering or a scientific field

Master's Degree or equivalent

Ph.D. or equivalent

Tools

Excel

PowerPoint

Project

Job description

The Senior Manufacturing Engineer provides advanced engineering expertise and technical leadership to improve and sustain manufacturing processes within a highly regulated medical device environment. This role supports critical manufacturing operations, driving improvements in yield, capacity, process robustness, compliance, and the implementation of new products, equipment, and manufacturing technologies.

This position supports second-shift manufacturing operations and requires a high degree of independence, technical ownership, and sound engineering judgment in an environment with limited on-shift engineering support.

Manufacturing Performance & Process Improvement

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability, capacity expansion, cost reduction, and operational risk mitigation.
• Identify, prioritize, and implement process optimization opportunities using structured problem-solving methodologies, statistical analysis, Lean Manufacturing, and continuous improvement principles.
• Serve as a technical leader and subject matter expert for manufacturing processes, equipment, and associated technologies.
• Partner with Operations, Quality, Supply Chain, Maintenance, and other cross-functional teams to improve manufacturing performance and achieve business objectives.

Technical Problem Solving & Compliance

• Lead investigations and resolution of complex manufacturing, quality, and compliance issues, including CAPAs, nonconformances, audit observations, process deviations, and customer-impacting events.
• Apply statistical techniques and data-driven decision-making to evaluate process performance, identify root causes, and implement effective corrective and preventive actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a manufacturing technical expert.
• Design and execute engineering studies, experiments, process validations, and equipment qualifications.
• Develop and execute protocols, analyze results, prepare technical reports, and recommend implementation strategies based on data and risk assessment.
• Support the introduction and integration of new products, equipment, manufacturing technologies, and process improvements while ensuring compliance, manufacturability, and operational readiness.
• Ensure manufacturing equipment, tooling, fixtures, and processes meet applicable safety, quality, performance, and regulatory requirements.

Technical Leadership & Project Execution

• Lead cross-functional projects from concept through implementation using project management tools, risk assessments, and structured execution plans.
• Influence engineers, technicians, operations personnel, and business partners to achieve project objectives without direct authority.
• Mentor engineers and technicians in engineering best practices, manufacturing process control, data analysis, and structured problem solving.
• Provide technical direction and training to technicians supporting manufacturing operations and engineering studies.
• Develop and maintain manufacturing documentation, work instructions, procedures, training materials, and engineering records.

Education & Experience

• Bachelor's Degree in Engineering or a scientific field with 4+ years of industry or combined industry/education experience; or
• Master's Degree or equivalent in Engineering or a scientific field with 3+ years of industry or combined industry/education experience; or
• Ph.D. or equivalent in Engineering or a scientific field with relevant industry or combined industry/education experience.

Required Qualifications

• Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
• Demonstrated ability to work independently and exercise sound engineering judgment.
• Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Project.
• Knowledge of applicable FDA regulations and quality system requirements.

Preferred Qualifications

• Experience in FDA-regulated manufacturing environments, preferably within medical device manufacturing.
• Experience with CAPA systems, nonconformance investigations, audit support, change control, and risk management.
• Experience applying Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis, and hypothesis testing.
• Experience supporting process validation and equipment qualification activities.
• Experience leading cross-functional manufacturing improvement projects with measurable business impact.
• Experience supporting new product transfers, equipment implementation, or manufacturing technology integration.
• Experience working with complex manufacturing equipment and automated production systems.