Process Engineer II

Process Engineer – Medical Device Manufacturing

We are seeking a Process Engineer to support new product development, manufacturing process implementation, equipment validation, and continuous improvement initiatives within a regulated medical device manufacturing environment. This individual will be responsible for assessing and improving manufacturing processes, driving validation activities, managing project timelines, coordinating suppliers and contractors, and ensuring compliance with FDA regulations, GMP requirements, and internal quality standards.

The ideal candidate will have experience with equipment and process validation (IQ/OQ/PQ), statistical analysis, process qualification, technical documentation, and cross-functional project management.

Key Responsibilities Process Engineering & Continuous Improvement

• Analyze and assess supplier and internal manufacturing processes to determine process capability and identify improvement opportunities.
• Design, develop, and optimize manufacturing processes and equipment to improve productivity, quality, and operational efficiency.
• Conduct feasibility studies, process evaluations, and statistical analyses to support implementation of new manufacturing technologies and processes.
• Develop process control strategies using data analysis, validation studies, and Statistical Process Control (SPC) methodologies.
• Support supplier assessment, qualification, and selection activities.

Validation & Qualification Activities

• Lead and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.
• Develop and execute validation protocols, test plans, and qualification documentation.
• Ensure validation activities comply with FDA regulations, GMP requirements, and company quality standards.
• Perform:
  • Preventive Maintenance Reviews
  • Environmental Health & Safety Assessments
  • Utility Verifications (Electrical, Pneumatic, Hydraulic Systems)
  • Software Verifications
  • Functional Testing
  • Calibration Verification Activities
  • Equipment Documentation Reviews
  • Training Program Development and Verification
• Ensure proper material, equipment, and data traceability throughout validation activities.
• Support protocol execution, discrepancy resolution, and final validation reporting.

Documentation & Compliance

• Author, review, and update:
  • Validation Protocols
  • Standard Operating Procedures (SOPs)
  • Test Protocols and Procedures
  • Engineering Drawings
  • Equipment Specifications
  • Training Materials
  • Raw Material Specifications
  • Change Control Documentation Packages
• Maintain accurate documentation within Quality Management Systems (QMS).
• Ensure compliance with FDA, GMP, OSHA, and internal quality requirements.

Project Management & Supplier Coordination

• Manage project timelines and site deliverables for equipment and process implementation projects.
• Coordinate activities with vendors, suppliers, contractors, quality teams, manufacturing personnel, and engineering stakeholders.
• Support equipment commissioning, startup, and process transfer activities.
• Present project updates, validation results, risk assessments, and cost-justification analyses to leadership.
• Prioritize multiple projects and rapidly address unplanned manufacturing issues and troubleshooting needs.

Operations Support

• Provide technical support for manufacturing operations and automated production equipment.
• Assist with troubleshooting, corrective actions, and process optimization initiatives.
• Maintain a clean and safe work environment while demonstrating a strong sense of urgency, ownership, and accountability.
• Communicate project status, risks, and issues effectively to leadership and stakeholders.

Required Qualifications Education

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or related engineering discipline.

Experience

• Minimum 2 years of engineering experience in a manufacturing environment.
• Experience within medical device manufacturing strongly preferred.
• Working knowledge of:
  • FDA regulations for medical device manufacturing
  • Good Manufacturing Practices (GMP)
  • Process Validation Methodologies (IQ/OQ/PQ)
  • Equipment Validation and Qualification
  • Change Control Documentation
  • Manufacturing Equipment and Automated Systems
• Experience developing and executing validation protocols and technical documentation.
• Project management experience supporting cross-functional initiatives.

Preferred Qualifications

• Experience within pharmaceutical or highly regulated manufacturing environments.
• Experience with printing systems and labeling management systems.
• Knowledge of AutoCAD and engineering design tools.
• Experience supporting equipment commissioning and startup activities.
• Familiarity with supplier qualification and vendor management processes.

Technical Skills

• Microsoft Office Suite (Excel, Word, PowerPoint, Project)
• Quality Management Systems (QMS)
• Minitab or equivalent statistical analysis software
• Agile methodologies
• Statistical Process Control (SPC)
• Data Analysis and Process Capability Studies
• Technical Documentation Development

Key Competencies

• Strong technical writing and documentation skills
• Excellent verbal and written communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities in a fast-paced environment
• Analytical problem-solving and troubleshooting skills
• Self-motivated and results-driven
• Strong interpersonal and vendor management skills
• Ability to work independently and collaboratively across multiple functions
• High level of integrity, accountability, and attention to detail

Ideal Candidate Profile

The ideal candidate has hands-on experience with medical device process validations (IQ/OQ/PQ), equipment qualification, statistical analysis, and technical documentation. They are comfortable managing suppliers, driving projects from conception through implementation, and ensuring all validation requirements are executed in accordance with regulatory and quality standards.

EEO Employer