Project Engineer

Description

We are seeking a Project Engineer to join our growing Engineering team. This is an exciting opportunity to play a pivotal role in scaling the manufacturing of an innovative Class III medical device, driving process validation, continuous improvement, and the implementation of new processes from development through production.

Responsibilities

• Lead process improvement initiatives for the company's flagship product.
• Plan, execute, and document manufacturing process validation activities.
• Validate existing production processes to ensure compliance, consistency, and efficiency.
• Support the development, implementation, and transfer of new manufacturing processes into production.
• Collaborate closely with cross-functional teams, including R&D, Engineering, Quality, Production, and Operations.
• Identify opportunities to optimize processes to improve product quality, manufacturability, and operational efficiency.
• Ensure all process validation activities are performed in accordance with applicable quality and regulatory requirements.

Reports to

Engineering Manager

Requirements

Experience

• A bachelor’s degree in mechanical or biomedical engineering, or a related field.
• 3-5 years of experience in product lifecycle development within the medical device industry.
• 1-3 years of hands-on experience with process validation activities, including technology transfer, IQ, DOE, OQ, and PQ.
• Experience with complex mechanical or materials-based manufacturing processes.
• Hands-on experience operating manufacturing equipment and production tools, with proven expertise in manufacturing process optimization.
• Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
• Familiarity with Process Validation Master Plans/Protocols (PVMP).
• Understanding of Test Method Validation processes.

Required Skills

• Proficiency in CAD software, particularly SolidWorks.
• Experience with data analysis and statistical software, such as JMP and/or Minitab.
• Strong problem-solving, analytical, and troubleshooting capabilities.
• Proven ability to work effectively within cross-functional teams.
• Strong written communication skills in English.
• Excellent interpersonal and relationship-building skills.