Expirienced Engineering Manager

Position Overview

We are seeking an experienced Engineering Manager to lead and oversee engineering activities in a fast-growing medical device company. This role is central to ensuring operational excellence, supporting new product introduction (NPI), managing production engineering, and maintaining site and systems to the highest standards of quality and compliance.

The Engineering Manager will collaborate closely with Operations, Quality, R&D, and Regulatory teams to ensure smooth product transfer, robust manufacturing processes, and continuous improvement in line with medical device regulations.

Key Responsibilities

Production Engineering:

• Support day-to-day production activities.
• Ensure manufacturing processes are efficient, reliable, and compliant with regulatory requirements (ISO 13485, FDA QSR, etc.).
• Drive root-cause analysis and corrective/preventive actions (CAPA) for production issues.
• Own the operation and maintenance of the clean room (ISO 7) environment. 
• Manage on going cost reduction intiatives 
• Manage and conduct IQ/OQ/PQ V&V activites on all company equipment and production rooms.

New Product Introduction (NPI):

• Manage the engineering aspects of product transfer from R&D to manufacturing.
• Develop, validate, and implement scalable production processes, fixtures, and equipment.
• Partner with cross-functional teams to ensure smooth design transfer and manufacturability.
• Work closly with manufacturing for the creation of batch recoreds. DHR files and QC test.

Systems Maintenance & Improvement:

• Oversee the maintenance, calibration, and qualification of production systems and equipment.
• Implement continuous improvement initiatives to optimize production efficiency, cost, and quality.
• Impliment EMS system for the management of service, preventive and break.

Compliance & Documentation:

• Ensure all engineering activities and documentation meet regulatory and quality standards.
• Contribute to audits, inspections, and technical reviews as the engineering representative.
• Manage the V&V activities

Required Experience and Qualifications:

• B.Sc. in Mechanical, Electrical, Chemical engineering, or related Engineering discipline (M.Sc. an advantage).
• 7+ years of experience in engineering roles, with at least 3 years in a leadership/management position in the medical device industry with clean rooms productoin activites – a must).
• Strong background in production engineering, NPI, and equipment/system maintenance.
• Deep knowledge of quality and regulatory standards (ISO 13485, FDA CFR 21 Part 820, ISO 63404, 14971 GAMP 5 computrized systems).
• Proven experience in leading cross-functional projects and driving improvements in a regulated environment.
• Experience with maintanance management, and maintanance Information Systems
• Experience in writing DHR, Work Instructions, Test Instructions.
• Excellent communication skills, problem-solving skills.
• Hands-on, proactive, resourceful and creative 
• Team player and collaborative mindset.
• Strong verbal and written communication skills in English

Preferred Qualifications:

• Experience with Class II/III implantable devices or other highly regulated medical technologies.
• Familiarity with validation protocols (IQ, OQ, PQ), risk management (ISO 14971), and design control processes.
• Track record of scaling production from prototype to commercial volumes.