Senior Manufacturing Engineer

Hydrogen UK Ltd; Draper (UT); On-site; USD 58,000 - 72,000; Full time

Job summary

Hydrogen UK Ltd seeks a Senior Manufacturing Engineer in Draper, UT to provide advanced engineering expertise and leadership for manufacturing processes in a regulated medical device setting. The role focuses on yield, capacity, robustness, compliance, and new tech implementation, with second-shift support and high independence.

The position requires a Bachelor's in Engineering with 4+ years of experience (or equivalent), strong problem-solving, data analysis, and DOE/SPC experience, and

Qualifications

• Bachelor’s or higher degree in engineering or scientific field with relevant experience.
• Experience in FDA-regulated manufacturing environments is preferred.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead manufacturing improvement initiatives focused on yield, capacity, and cost reduction.
• Identify and implement process optimization using DOE, SPC, and Lean methods.
• Lead investigations of complex manufacturing, quality, and compliance issues.
• Design and execute studies, validations, and equipment qualifications.
• Provide technical direction and mentor engineers and technicians.

Skills

Lean Manufacturing

Statistical Analysis

Problem Solving

Cross-Functional Collaboration

Project Management

Data Analysis

FDA Regulations Knowledge

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering

Ph.D. in Engineering

Tools

Microsoft Office Suite (Excel, PowerPoint, Project)

Job description

Title: Senior Manufacturing Engineer

Pay: $42.00-$52.00/hr
Location: Draper, UT
Schedule: Standard Office Hrs
Duration: 6-Month Contract
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.

Key Responsibilities

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.

Validation, Equipment & Technology Implementation

• 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.