Process Engineer

We are seeking a Process 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.

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.