Manufacturing Engineer

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

We are 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 closely with Quality, R&D, Validation, Operations, and Supply Chain teams to ensure manufacturing processes are robust, efficient, compliant, and capable of consistently producing high-quality medical devices.

Key Responsibilities

• Develop, implement, optimize, and maintain manufacturing processes for medical device products.
• Provide day-to-day manufacturing engineering support to production and resolve technical issues affecting manufacturing operations.
• Troubleshoot equipment, process, tooling, and production issues and implement effective corrective actions.
• Develop and improve manufacturing processes to increase productivity, yield, quality, and process capability.
• Support introduction of new products and transfer products from R&D/design into manufacturing.
• Develop and maintain manufacturing documentation, including work instructions, Standard Operating Procedures (SOPs), manufacturing procedures, and process specifications.
• Support equipment selection, installation, commissioning, qualification, and process validation activities.
• Develop and execute engineering studies, process trials, Design of Experiments (DOE), and process capability assessments.
• Participate in PFMEA, process risk assessments, control plans, and other risk-management activities.
• Support root cause investigations for manufacturing deviations, nonconformances, defects, and customer complaints.
• Implement corrective and preventive actions (CAPA) and continuous improvement initiatives.
• Evaluate manufacturing processes for compliance with applicable quality and regulatory requirements.
• Support Engineering Change Orders (ECOs), Change Controls, and product/process changes.
• Work with Quality Engineering to investigate process-related failures and establish appropriate corrective actions.
• Analyze manufacturing data and production metrics to identify trends, process issues, and opportunities for improvement.
• Support Lean Manufacturing, Six Sigma, Kaizen, and other continuous improvement initiatives.
• Develop and optimize tooling, fixtures, manufacturing equipment, and production methods.
• Collaborate with suppliers and external partners on manufacturing process and equipment-related activities.
• Support equipment maintenance, troubleshooting, and preventive maintenance strategies as required.
• Ensure manufacturing processes are properly documented and controlled in accordance with company procedures.
• Provide technical support during audits and assist with responses to manufacturing-related observations.
• Ensure all engineering activities comply with applicable medical device regulations, quality systems, and company standards.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or a related engineering discipline.
• 3+ years of manufacturing engineering experience, preferably within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Hands-on experience supporting manufacturing processes, production equipment, tooling, and process improvement.
• Experience working within a regulated FDA/ISO 13485 manufacturing environment.
• 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 effectively with cross‑functional teams in a fast‑paced manufacturing environment.

Preferred Qualifications

• Experience with ISO 13485, FDA 21 CFR Part 820/QMSR, and applicable medical device regulations.
• Experience with IQ/OQ/PQ and process validation.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Experience with PFMEA, Control Plans, SPC, DOE, and statistical analysis.
• Lean Manufacturing or Six Sigma certification.
• Experience with automated manufacturing equipment, robotics, or machine vision systems.
• Experience with injection molding, extrusion, CNC machining, assembly, sterilization, packaging, or other medical device manufacturing processes.
• Experience supporting New Product Introduction (NPI) and product transfers.
• Experience with CAD tools such as SolidWorks, AutoCAD, or Creo.
• Familiarity with ERP/MRP and manufacturing data systems.