Manufacturing Engineer (Medical Device -MC)

Spectrum Assembly, Inc.; Carlsbad (CA); On-site; USD 85,000 - 105,000; Full time

Job summary

Spectrum Assembly, Inc. (SAI Corp.) in Carlsbad, CA, seeks a practical Manufacturing Engineer to improve production processes, documentation, and line performance on the shop floor.

You will partner with Production, Quality, Operations and Engineering to analyze data, troubleshoot on the floor, support new product introductions, and implement sustainable improvements with cross‑functional teams.

Qualifications

• Bachelor’s degree in engineering or 5+ years of practical experience in manufacturing.
• Proven manufacturing engineering experience in a production environment.
• Strong problem-solving, analytical, and communication skills.
• Experience with process improvement, root-cause analysis, and data-driven decision-making.
• Working knowledge of manufacturing processes and workflow optimization.
• Familiarity with Lean, 6S, and SPC methodologies.
• Ability to read engineering drawings, specifications, and CAD models.
• Knowledge of tooling, fixtures, and equipment on the shop floor.
• Experience in regulated environments such as medical devices is a plus.

Responsibilities

• Improve processes, line balance, and production efficiency.
• Develop and maintain production documentation and Device History Records (DHRs).
• Analyze production data to identify bottlenecks, variation, downtime, and defects.
• Support SPC, process validation, and quality initiatives.
• Partner with Quality for root-cause investigations and CAPA.
• Evaluate manufacturability and cost impact of process changes.
• Support new product introductions and engineering changes.
• Provide hands-on floor support for setup, troubleshooting, and improvements.
• Collaborate with cross-functional teams to implement solutions on the production floor.
• Support Lean, 6S, and continuous improvement initiatives.

Education

Bachelor's degree in Manufacturing/Mechanical/Industrial Engineering or 5+ years of equivalent experience

Tools

CAD

ERP/MRP

Excel

Job description

Spectrum Assembly, Inc. (SAI Corp.) is seeking a practical, analytical Manufacturing Engineer who enjoys working on the production floor and partnering with Production, Quality, Operations, Engineering, and customers to solve problems and drive measurable improvements. This role is responsible for improving manufacturing processes, production documentation, process capability, line performance, product quality, and overall operational excellence.

The ideal candidate is a hands‑on engineer who can move comfortably between analyzing production data, troubleshooting a process on the floor, improving documentation, supporting new product introduction, and working with operators and cross‑functional teams to implement sustainable solutions.

Responsibilities

• Improve manufacturing processes, workflows, line balance, and production efficiency.
• Develop, update, and maintain clear production documentation, work instructions, and Device History Records (DHRs).
• Analyze production data to identify bottlenecks, process variation, downtime, defects, and opportunities for improvement.
• Support process capability, statistical process control (SPC), process validation, and other data‑driven quality initiatives.
• Partner with Quality to conduct root‑cause investigations and implement effective, sustainable corrective and preventive actions.
• Evaluate manufacturing processes for quality, efficiency, manufacturability, and cost effectiveness.
• Support new products, engineering changes, and process changes as they transition into production.
• Provide hands‑on engineering support for production line setup, equipment and process troubleshooting, and day‑to‑day manufacturing challenges.
• Partner with operators and cross‑functional teams to identify problems, develop solutions, and implement improvements on the production floor.
• Support Lean, 6S, and other continuous improvement initiatives.
• Communicate technical findings, recommendations, and project status clearly to both technical and non‑technical stakeholders.

Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, Industrial Engineering, or a closely related field, or 5+ years of equivalent practical technical experience.
• Manufacturing engineering experience in a production environment.
• Strong problem‑solving, analytical, and communication skills.
• Experience with process improvement, root‑cause analysis, manufacturing documentation, and data‑driven decision‑making.
• Working knowledge of manufacturing processes, workflow optimization, and process control.
• Familiarity with Lean manufacturing, 6S, SPC, and continuous improvement methodologies.
• Ability to interpret engineering drawings, specifications, and CAD models.
• Knowledge of mechanical engineering principles related to tooling, fixtures, equipment, and manufacturing processes.
• Experience in medical device or other regulated manufacturing environments is preferred; familiarity with FDA and ISO 13485 requirements is a plus.
• Proficiency with Microsoft Office, particularly Excel for data analysis; experience with ERP/MRP systems is a plus.
• Ability to work effectively with production personnel, engineering, quality, operations, and customers.
• Hands‑on approach with a willingness to spend significant time on the production floor.

Why Join Spectrum Assembly?

This is an opportunity to make a direct impact on quality, productivity, process stability, and continuous improvement in a high‑tech contract manufacturing environment. Spectrum Assembly supports medical, industrial, aerospace, and other technology‑driven applications from its Carlsbad manufacturing operation, with capabilities spanning PCB assembly, cable and wire harnesses, and system integration.