onsite
Project Engineer - 30-Month Fixed Term - INTERSURGICAL
Software Engineer
Project Engineer to lead technical delivery of a new production line in a regulated medical device manufacturing environment, ensuring equipment specification, installation, commissioning, and validation meet GMP and regulatory standards.
About the role
Key Responsibilities
- Lead the technical specification, procurement, and installation of production line equipment, ensuring compliance with GMP and regulatory requirements.
- Coordinate commissioning, qualification, and validation activities, documenting all processes and outcomes.
- Collaborate with cross‑functional teams, suppliers, and internal stakeholders to maintain project timelines and quality standards.
- Develop and maintain project documentation, including risk assessments, change control records, and validation protocols.
- Provide technical support during production ramp‑up and troubleshoot equipment performance issues.
Requirements
- Degree in Engineering or related field with experience in medical device manufacturing.
- Strong knowledge of GMP, ISO 13485, and validation processes.
- Proven project management skills and ability to deliver on schedule.
- Excellent communication and stakeholder management abilities.
- Experience with equipment specification and supplier management in a regulated environment.