Process Engineer - Medical Device Manufacturing

Process Engineer - Medical Device Manufacturing
Location: Waltham, MA (100% Onsite)
Duration: 12-Month Contract (Potential for Extension)

Position Overview
We are seeking an experienced Process Engineer to support the development, transfer, optimization, and validation of manufacturing processes for innovative medical device products. This role will play a key part in scaling production operations, partnering with internal teams and external suppliers to ensure robust, compliant, and efficient manufacturing processes within a regulated medical device environment.

The ideal candidate will bring strong expertise in process validation, statistical analysis, and manufacturing process development, along with the ability to independently solve complex technical challenges and drive continuous improvement initiatives.

Key Responsibilities

• Lead manufacturing process development, transfer, optimization, and validation activities, including IQ/OQ/PQ execution and documentation.
• Support both internally developed and externally sourced manufacturing processes within regulated medical device environments.
• Apply statistical methods and data-driven problem-solving techniques to improve process performance and product quality.
• Design and execute process characterization studies, Design of Experiments (DOE), process capability analyses, and root cause investigations.
• Develop and maintain process validation protocols, reports, specifications, and technical documentation.
• Collaborate with quality, operations, suppliers, and engineering teams to identify and resolve manufacturing challenges.
• Conduct risk assessments using tools such as FMEA and support control plan development and design transfer activities.
• Troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.
• Interpret engineering drawings and GD&T requirements for precision components and assemblies.
• Support manufacturing readiness, scale-up activities, and process improvements while ensuring compliance with applicable quality system and regulatory requirements.
• Manage multiple projects and priorities while operating with a high degree of independence.

Required Qualifications

• Strong experience with medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
• Experience supporting medical device capital equipment manufacturing processes.
• Proficiency with Minitab or similar statistical analysis software.
• Strong understanding of statistical methods and data-driven problem solving, including:
  • Design of Experiments (DOE)
  • Process characterization
  • Process capability analysis
  • Root cause investigation
• Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer.
• Ability to read, interpret, and create engineering drawings, including GD&T requirements.
• Strong technical writing and documentation skills.
• Ability to perform complex statistical, geometric, and mathematical calculations.
• Demonstrated ability to work independently with minimal supervision.
• Excellent project management and organizational skills.
• Strong commitment to patient safety, product quality, and regulatory compliance.

Preferred Qualifications

• Experience with complex medical device manufacturing processes such as:
  • Catheter assembly
  • Balloon processing
  • Laser processing
  • Extrusion
  • Thermal forming / heat setting
  • Bonding
  • Precision assembly
  • Injection molding
• Experience with electro-mechanical or capital equipment manufacturing.
• Six Sigma Green Belt or Black Belt certification.
• Experience working with external suppliers and contract manufacturers.

Additional Information

• This position is 100% onsite in Waltham, MA.
• Candidates must be comfortable working in a fast-paced, collaborative environment.
• The successful candidate will be expected to become productive quickly following onboarding and operate with a high degree of autonomy.
• Opportunity exists for long-term growth as the organization continues to expand.

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