Senior Manufacturing Engineer / Manufacturing Manager (Medical Devices)

Regulatory Affairs & Compliance:
 

1. Manufacturing Process Development & Compliance – Define, validate, and scale up manufacturing equipment and processes for Class I & II products in line with ISO 13485, FDA (21 CFR Part 820), and EHS requirements.
2. Process Optimization & Continuous Improvement – Enhance existing processes to improve efficiency, yield, and cost-effectiveness, while driving Lean/Six Sigma initiatives to eliminate waste and ensure quality.
3. Technology & Product Introduction – Lead implementation of new technologies, materials, and processes, and support new product introduction through DFM, process development, and production readiness.
4. Cross-Functional & Vendor Collaboration – Partner with engineering, QA, supply chain, regulatory, and contract manufacturers to resolve issues (CAPA), develop documentation, and ensure smooth product lifecycle management.

 

1. Bachelor’s Degree in Engineering (Mechanical / Biomedical / Manufacturing) with minimum 8-10 years’ experience in the medical devices industry. You should be familiar with setting up of manufacturing line, developing processes as well as optimisation.
2. Must be able to speak English and Mandarin (in order to deal with suppliers in China)
3. Comfortable with being the 1st dedicated hire in manufacturing to take on all manufacturing related tasks and issues.
4. Good knowledge and experience with various manufacturing processes eg. automation, semi-automation, assembly, injection molding, extrusion, blow molding, leak tester, packaging sealing, ultrasonic welding, UV adhesive curing etc.
5. Develop manufacturing processes for medical devices using methodologies such as Design Thinking, DFM and DFSS techniques.
6. Hands-on experience with equipment qualification and buy-off of manufacturing equipment with contract manufacturers.
7. Hands-on experience with process validation, test method validation (MSA, GR&R), risk management with responsibility in developing process FMEA, root cause analysis and CAPA.

About the company:
 

1. American startup with senior management team; based in Europe
2. Hybrid work arrangement – 2 days in office, 3 days working from home
3. Excellent medical insurance coverage
4. Good variable bonus structure
5. Great working culture
6. Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to hr@searchstaffing.com.sg stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at 6749 4236.
 
 

EA Personnel Registration No: R1324700