Senior Manufacturing Engineer – Manufacturing Line / NPI

Pyramid Consulting, Inc; San Diego (CA); On-site; USD 138,000 - 142,000; Full time

Job summary

Pyramid Consulting, Inc. is seeking a Senior Manufacturing Engineer to lead manufacturing lines and NPI efforts in San Diego, CA on site. This 12+ month contract role focuses on line launches, ramp-ups, and continuous improvement of processes, equipment, and layouts.

The candidate will drive validation, qualification, and change control while collaborating with Quality, R&D, and Operations. Medical device/pharma experience and familiarity with PLCs, machine vision, and SAP/MES are preferred.

Qualifications

• Bachelor's degree in a engineering discipline as listed.
• 7+ years of manufacturing/process engineering experience; advanced degree 5+ years.
• Experience in regulated manufacturing (medical device/pharma/biotech).
• Hands-on with process validation and equipment qualification.

Responsibilities

• Provide technical leadership for manufacturing lines and NPI.
• Lead line launches, ramp-up, and hypercare activities.
• Develop and optimize processes, layouts, equipment, tooling, and assembly.
• Lead validation, qualification, and change-control activities.
• Support installation, commissioning, and optimization of equipment.
• Analyze production performance using OEE, yield, throughput, and scrap.

Skills

OEE analysis

Statistical analysis (Minitab)

Process validation

Equipment qualification

PLC-controlled equipment

Machine vision

CAPA

Change control

Technology transfer

Cross-functional leadership

Education

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Electrical Engineering

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Job description

Immediate need for a talented Senior Manufacturing Engineer – Manufacturing Line / NPI. This is a 12+ Months Contract opportunity with long-term potential and is located in San Diego , CA (Onsite).

Job ID:26-29669

Pay Range: $100 - $103/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)

Key Responsibilities:

• Provide technical leadership and engineering ownership for manufacturing and production lines.
• Support manufacturing line launch, NPI, production ramp-up, and hypercare activities.
• Develop, optimize, and improve manufacturing processes, production layouts, equipment, tooling, and assembly operations.
• Lead process validation and equipment qualification activities.
• Support installation, integration, commissioning, and optimization of manufacturing equipment.
• Troubleshoot and improve semi-automated manufacturing equipment, PLC-controlled systems, machine interfaces, and vision inspection systems.
• Analyze production performance using OEE, yield, throughput, capacity, scrap, and efficiency metrics.
• Identify opportunities to improve manufacturing capacity, quality, yield, and overall equipment effectiveness.
• Apply SPC, statistical analysis, root cause analysis, and continuous improvement methodologies to manufacturing problems.
• Lead technical investigations and corrective actions related to equipment, process, and quality issues.
• Support manufacturing changes through appropriate change-control and engineering documentation processes.
• Partner with Quality to ensure compliance with applicable FDA Quality System Regulations and ISO 13485 requirements.
• Support manufacturing scale-up, technology transfer, process development, and product launches.
• Provide technical leadership for capital equipment, automation, and manufacturing technology projects.
• Evaluate manufacturing equipment, tools, processes, and technologies for performance, reliability, and scalability.
• Develop manufacturing procedures, process documentation, validation documentation, and technical reports.
• Collaborate with Operations, Quality, R&D, Supply Chain, and other stakeholders to resolve manufacturing challenges.
• Mentor and provide technical guidance to Manufacturing Engineers and Process Engineers.

Key Requirements and Technology Experience:

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Electrical Engineering, or related engineering discipline.
• 7+ years of relevant manufacturing/process engineering experience, or an advanced degree with 5+ years of relevant experience.
• Strong experience in a manufacturing or production environment.
• Hands-on experience with process validation and equipment qualification.
• Experience with semi-automated manufacturing equipment.
• Experience with PLC-controlled equipment and machine interfaces.
• Experience with machine vision / vision inspection systems.
• Strong understanding of OEE, yield, throughput, capacity, scrap, and manufacturing performance metrics.
• Experience with root cause analysis and continuous improvement.
• Experience supporting NPI, manufacturing scale-up, production launch, or technology transfer.
• Strong project planning, technical problem-solving, and cross-functional leadership skills.
• Medical device, pharmaceutical, biotechnology, or other regulated manufacturing experience.
• Experience with FDA Quality System Regulations.
• Experience with ISO 13485.
• Experience with plastic injection-molded components and welding/assembly processes.
• Capital equipment and automation project experience.
• Experience with manufacturing systems such as SAP or MES.
• Experience with AutoCAD or SolidWorks.
• Experience with Minitab or other statistical analysis tools.
• Experience with manufacturing change control and CAPA.
• Experience leading technical teams or mentoring engineers.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.