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.