Medical Device Process Engineer — NPI & Improvement

United Pharma; California; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking an experienced Medical Device Manufacturing Engineer to support manufacturing operations, process development, continuous improvement, and production engineering activities within a regulated medical device manufacturing environment.

The successful candidate will work with Quality, R&D, Validation, Operations, and Supply Chain teams to ensure manufacturing processes are robust, compliant, and capable of consistently producing high-quality medical devices.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or related field.
• 3+ years manufacturing engineering experience in regulated environments.
• Hands-on experience with manufacturing processes, equipment, tooling, and improvement.
• Experience in FDA/ISO 13485 manufacturing environments.
• Strong understanding of manufacturing processes, process controls, and quality systems.
• Experience with root cause analysis and problem-solving methodologies.
• Experience with process validation and qualification activities.
• Strong technical documentation and communication skills.
• Ability to work with cross-functional teams in a fast-paced environment.

Responsibilities

• Develop, implement, optimize, and maintain manufacturing processes for medical device products.
• Provide day-to-day manufacturing engineering support to production and resolve issues.
• Troubleshoot equipment, process, tooling, and production issues; implement corrective actions.
• Develop and improve processes to increase productivity, yield, quality, and capability.
• Support transfer of products from R&D/design into manufacturing.
• Develop and maintain manufacturing documentation (SOPs, work instructions, specs).
• Support equipment selection, installation, qualification, and validation activities.
• Plan and conduct DOE, process capability assessments.
• Participate in PFMEA, control plans, and risk assessments.
• Support CAPA and continuous improvement initiatives.

Skills

3+ years manufacturing engineering

Root cause analysis

Technical documentation

Process validation

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Biomedical Engineering

Tools

SolidWorks

AutoCAD

Creo

Job description

United Pharma is seeking an experienced Medical Device Manufacturing Engineer to support manufacturing operations, process development, continuous improvement, and production engineering activities within a regulated medical device manufacturing environment.

The successful candidate will work with Quality, R&D, Validation, Operations, and Supply Chain teams to ensure manufacturing processes are robust, compliant, and capable of consistently producing high-quality medical devices.