NPI Engineer- Medical Device

Support production lines for medical devices in aspects of Mechanical engineering from design for manufacturability, through NPI (Transfer from R&D to commercial production) to sustaining of the lines and ongoing support.

Major duties and responsibilities:

1. Design for manufacturability:

1.1. Work closely with the R&D and System engineering team to provide inputs for Design for manufacturability.

1.2. Participate in Design Reviews.

2. Define manufacturing processes:

2.1. Define, in collaboration with R&D, the mechanical aspects of commerical manufacturing processes of the device and its testing.

2.2. Define, build and qualify the mechanical aspects of the engineering lines to provide samples for testing during the development process.

2.3. SME in mechanicval aspects for pFMEAs and their integration into other risk deliverables.

3. Mechanical aspects of transfer to production to subcontractors:

3.1. Owner of the validation of the mechanical aspects of commercial manufacturing process.

3.2. Approve operation/maintenance procedures for commertial manufacturing mechanical processes/tools/tests.

3.3. Work with R&D and QA to complete the Transfer to production design phase including formalizing the DMR (Device Master Record).

4. Be the SME for sustaining activities.

5. Lead scale up activities of commerical lines.

6. Changes to commercial lines (improvements, failure investigation, change location, duplication):

6.1. SME in failure investigation and melfunctions in production line that impact the product function/quality.

Requirements:

1. Fluent English verbal and writing.

2. Experience in NPI of medical devices.

3. Experianced in managing/colaboration with sub-contractors.

4. Well experianced with automated manufacturing equipment:

o Automatic feeding of components, e.g: Bowl feeders linear feeders.

o Heigh rate automated assembly equipmentof plastic rigid and soft parts, 20 – 40 pcs/min.

5. Well experianced with risk assessment evaluations, pFMEA documentation and implementation.

6. Well experianced with equipment qualification processes, Instalation Qualification

(IQ), Operation Qualification (OQ), Process qualification (PQ).

7. Quick learner, Team player, height level orgenized abilities.

8. Experience with FDA QSR and ISO 13485 medical device regulations.

9. Experience with CAD systems.

Education and Knowledge Requirements:

· Mechanical Engineer with At least 10 years of experience in in the Medical devices industry.

· Experience in PCB assmelby an advantage.

· Knowledge with document control systems and PLM systems.

Reports To: Device Engineering Director

Note: Any equivalent combination of education, training and/or experience that

fulfills the requirements of the position may be considered.

Travel Requirements: 15%. International Travel required.