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Senior Manufacturing Engineer – Medical Devices (NPI & Process Validation)
Pyramid Consulting, Inc
🇺🇸 United States
On-site
Senior
1 week ago
- Minitab
- SAP
- AutoCAD
- SolidWorks
- SPC
- Lean
1 week ago
Job ID:26-26446
Pay Range: $75 - $80/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)
Key Responsibilities:
- Develop, optimize, and implement manufacturing processes for medical device products.
- Support New Product Introduction (NPI) and commercialization activities.
- Develop manufacturing processes, production layouts, tooling, material handling systems, and semi-automated equipment.
- Lead and support process validation and equipment qualification, including IQ, OQ, and PQ.
- Support equipment installation, commissioning, qualification, and production readiness.
- Develop manufacturing test methods and process documentation.
- Create and maintain manufacturing specifications, work instructions, procedures, and engineering documentation.
- Analyze manufacturing processes to improve yield, throughput, capacity, quality, reliability, and efficiency.
- Identify and resolve manufacturing bottlenecks and process issues.
- Conduct root cause analysis using methodologies such as 5 Why, Fishbone/Ishikawa, and statistical analysis.
- Drive corrective actions and continuous improvement initiatives.
- Partner with equipment suppliers and internal engineering teams to improve equipment performance and reliability.
- Support automation and advanced manufacturing technology initiatives.
- Use statistical and process-control techniques to monitor and improve manufacturing performance.
- Support production ramp-up and manufacturing transfer activities.
- Ensure manufacturing processes comply with applicable FDA QSR and ISO 13485 requirements.
- Provide technical leadership for complex manufacturing engineering issues.
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related engineering discipline.
- 4+ years of relevant manufacturing engineering experience; advanced degree with 2+ years of relevant experience may also be considered.
- Strong medical device manufacturing experience.
- Hands-on experience with process validation and equipment qualification.
- Experience with IQ/OQ/PQ.
- Experience with manufacturing equipment, process optimization, and production support.
- Strong knowledge of statistical analysis and process control.
- Experience with structured root cause analysis and problem solving.
- Experience supporting NPI, commercialization, or production ramp-up.
- Ability to work in a regulated manufacturing environment.
- Strong technical documentation, communication, and cross-functional collaboration skills.
- Minitab
- SAP
- MES
- AutoCAD
- SolidWorks
- Manufacturing automation
- Semi-automated equipment
- Statistical Process Control (SPC)
- Process capability analysis
- Equipment qualification
- Manufacturing test methods
- Lean / continuous improvement methodologies
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Senior Manufacturing Engineer – Medical Devices (NPI & Process Validation) · Pyramid Consulting, Inc