Process Design Engineer / Equipment Engineer, Singapore

Project Planning & Timeline Definition: Participate in early project phases (projects, pre-projects, exploratory studies) by contributing to project planning, gathering requirements, and defining equipment specifications. Define equipment and process design activities, establishing clear engineering tasks aligned with engineering and quality standards to ensure timely project delivery.

Equipment & Process Design, Installation and Validation: Lead the design, development, and integration of equipment in compliance with ISO13485 and applicable regulatory standards. Evaluate manufacturing solutions and ensure alignment with product and production requirements. Conduct gap analyses (technology, workforce, capabilities) to ensure successful transfer to production. Perform risk analyses and identify critical success factors for equipment and process implementation. Prepare engineering requirements, business cases, and CAPEX proposals for new equipment and processes. Develop equipment specifications, manage supplier selection, conduct tender evaluations, and support purchase order awards. Lead design reviews (internal and external) and manage investment projects using structured project management methodologies. Ensure proper qualification and validation activities, including FAT, SAT, IQ, and participation in process validation activities.

Prototyping & Industrialization Support: Monitor emerging technologies and equipment developments in the market. Develop and implement prototyping capabilities to support R&D and innovation projects. Ensure smooth transition from prototyping phases to full industrial production.

• 6-10 years of experience in Equipment and Process Engineering in the medical device industry.
• Masters OR Bachelors in Engineering (Mechanical, Industrial, OR related field).
• Experience in equipment sourcing & qualification, commissioning and documentation.
• Know‑how in process validation (IQ, OQ, PQ) and ISO13485.
• Excellent communication and stakeholder management skills.
• Fluent in English.

Linxens is an equal‑opportunity employer that strictly prohibits unlawful or unethical discrimination. Moreover, as part of its CSR Vitality program, it has committed to recruit, hire, train, compensate, and promote without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental or physical disability, marital status, or any other characteristic protected by law.