Senior Manufacturing Engineer

Location: Draper, UT

Schedule: 2nd Shift

Contract Duration: 12 Months

Pay Rate:$52-57/hr

Position Overview

The Senior Manufacturing Engineer will apply advanced engineering knowledge, technical leadership, and manufacturing expertise to improve and sustain manufacturing processes within a highly regulated medical device environment.

This role serves as a technical leader supporting critical implantable component manufacturing operations, with responsibility for driving:

• Yield improvement
• Capacity expansion
• Process robustness
• Cost reduction
• Risk mitigation
• Regulatory and compliance excellence

The successful candidate will use structured problem solving, statistical analysis, Lean Manufacturing, and cross-functional collaboration to resolve complex manufacturing challenges and deliver measurable improvements.

The Senior Manufacturing Engineer will support existing commercial product lines while also contributing to the integration of next-generation products, equipment, and manufacturing technologies.

This position supports 2nd-shift manufacturing operations and requires a high degree of independence, technical ownership, and sound engineering judgment due to limited on-shift engineering support.

Key Responsibilities

1. Manufacturing Performance & Process Improvement

• Lead complex manufacturing improvement initiatives focused on:
  • Yield stabilization
  • Process capability improvement
  • Capacity expansion
  • Cost reduction
  • Operational risk mitigation
• Identify, prioritize, and implement process optimization opportunities using:
  • Structured problem-solving methodologies
  • Statistical analysis
  • Lean Manufacturing
  • 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.

2. Technical Problem Solving & Compliance

• Lead investigations and resolution of complex manufacturing, quality, and compliance issues, including:
  • CAPAs
  • Nonconformances
  • Audit observations
  • Process deviations
  • Customer-impacting events
• Apply data-driven decision-making and statistical techniques to:
  • Evaluate process performance
  • Identify root causes
  • Develop corrective and preventive actions
  • Verify effectiveness of solutions
• Support regulatory inspections, internal audits, and compliance initiatives as a manufacturing technical expert.

3. Validation, Equipment & Technology Implementation

• Design and execute:
  • Engineering studies
  • Experiments
  • Process validations
  • 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
  • Manufacturing equipment
  • Manufacturing technologies
  • Process improvements
• Ensure new and existing processes are compliant, manufacturable, and operationally ready.
• Ensure manufacturing equipment, tooling, fixtures, and processes meet safety, quality, performance, and regulatory requirements.

4. Technical Leadership & Project Execution

• Lead cross-functional projects from concept through implementation using:
  • Project management tools
  • Risk assessments
  • Structured execution plans
• Influence engineers, technicians, operations personnel, and business partners without direct authority.
• Mentor engineers and technicians in:
  • Engineering best practices
  • Manufacturing process control
  • Data analysis
  • 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
  • Engineering records
• Support operational excellence and effective knowledge transfer across the organization.

5. Other Duties

• Perform other incidental duties as assigned by leadership.

Education & Experience

Bachelor's Degree:

Bachelor's degree in Engineering or a Scientific field with 4+ years of industry or industry/education experience.

Master's Degree:

Master's degree or equivalent in Engineering or a Scientific field with 3+ years of industry or industry/education experience.

Ph.D.:

Ph.D. or equivalent in Engineering or a Scientific field with relevant industry or industry/education experience.

Required Qualifications

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

Preferred Qualifications

• Experience working in an FDA-regulated manufacturing environment, preferably medical device manufacturing.
• Experience with:
  • CAPA systems
  • Nonconformance investigations
  • Audit support
  • Change control
  • Risk management
• Experience applying statistical and analytical methodologies, including:
  • Design of Experiments (DOE)
  • Statistical Process Control (SPC)
  • Process capability analysis
  • Hypothesis testing
• Experience supporting:
  • Process validation
  • Equipment qualification
• Demonstrated experience leading cross-functional manufacturing improvement projects with measurable business impact.
• Experience supporting:
  • New product transfers
  • Equipment implementation
  • Manufacturing technology integration
• Experience working with complex manufacturing equipment and automated production systems.

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