Medical Device Manufacturing Engineer Onsite & Validation

Philips Iberica SAU; Bedford (MA); On-site; USD 107,000 - 170,000; Full time

Benefits offered by this job

PTO

401k with match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips seeks an Advanced Manufacturing Engineer for Bedford, MA to drive process validation, troubleshooting, and continuous improvements in medical device manufacturing.

You will lead IQ/OQ/PQ activities, collaborate across production, quality, maintenance, and engineering, and develop documentation to ensure quality and regulatory compliance. This is an onsite role with a strong manufacturing focus and cross-functional teamwork.

Qualifications

• 5+ years of experience supporting manufacturing operations, process validation, production engineering, or related engineering functions.
• Experience in regulated industries such as medical devices, pharmaceuticals, biotechnology, or other highly controlled manufacturing environments is preferred.
• Knowledge of Lean Manufacturing and Six Sigma methodologies; statistical analysis and data analytics is beneficial.

Responsibilities

• Support daily manufacturing operations by troubleshooting production processes and equipment issues, identifying root causes, and implementing sustainable corrective actions to minimize downtime and improve productivity.
• Lead and support process validation activities, including IQ, OQ, and PQ, ensuring equipment and manufacturing processes meet quality and regulatory requirements.
• Partner with production, quality, maintenance, and engineering teams to improve yields, cycle times, product quality, and overall manufacturing performance through data-driven process improvements.
• Develop, maintain, and improve manufacturing documentation, work instructions, validation protocols, and technical procedures while ensuring compliance with applicable quality and safety standards.
• Drive continuous improvement initiatives by analyzing manufacturing data, identifying opportunities for optimization, and implementing solutions that improve efficiency, reliability, and operational excellence.

Skills

Root Cause Analysis

process troubleshooting

continuous improvement

manufacturing process development

equipment qualification

process validation

Lean Manufacturing

Six Sigma

statistical analysis

manufacturing data analytics

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biomedical Engineering

Tools

Python

SQL

Power BI

Job description

Philips seeks an Advanced Manufacturing Engineer for Bedford, MA to drive process validation, troubleshooting, and continuous improvements in medical device manufacturing.

You will lead IQ/OQ/PQ activities, collaborate across production, quality, maintenance, and engineering, and develop documentation to ensure quality and regulatory compliance. This is an onsite role with a strong manufacturing focus and cross-functional teamwork.