Process Engineer

Job Title: Process Engineer
Location: Waltham, Massachusetts
Type: Contract
Compensation: $45.00 - $51.00 per hour
Work Model: Onsite

Join a leading global medical technology organization focused on life-changing healthcare innovation and high-quality manufacturing excellence. This contract opportunity is ideal for an experienced manufacturing/process engineer with expertise in medical device process development, validation, and optimization, offering hands-on involvement with advanced capital equipment, statistical analysis, and complex catheter-based manufacturing processes in a highly collaborative, regulated environment.

Responsibilities

• Support medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ), with a focus on capital equipment
• Support both internally developed and externally sourced manufacturing processes within regulated environments
• Apply statistical methods and data-driven problem solving techniques, including DOE, process characterization, process capability analysis, and root cause investigation
• Utilize Minitab or similar statistical software for analysis and process improvement
• Implement risk management and design control methodologies, including FMEA, control plans, and design transfer activities
• Participate in manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and injection molding as needed
• Work with electro-mechanical and capital equipment manufacturing processes if required
• Troubleshoot complex manufacturing and process issues and implement corrective and preventive actions
• Read, interpret, and create engineering drawings, including GD&T for tight-tolerance components
• Perform complex statistical, geometric, and mathematical calculations
• Operate independently with minimal supervision on responsibilities
• Ensure compliance with quality systems and regulatory requirements, demonstrating commitment to patient safety and product quality
• Present and defend technical positions within a collaborative environment
• Manage multiple projects and tasks effectively
• Write and review protocols, reports, specifications, and technical documentation

Requirements

• Strong understanding of medical device manufacturing process development, transfer, optimization, and validation, specifically related to medical device capital equipment
• Proficiency in Minitab or similar statistical software
• Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation
• Experience supporting complex manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, and injection molding
• Ability to troubleshoot complex manufacturing issues and implement effective corrective actions
• Ability to interpret engineering drawings and technical specifications, including GD&T
• Strong mathematical and statistical analysis skills
• Excellent project management and technical communication skills

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific