Manufacturing Engineer

5 days ago


Pasir Ris, Singapore Fong’s Engineering & Manufacturing Pte Ltd Full time

**Manufacturing Engineer (SG ENDOSCOPY PTE LTD)**

**JOB DESCRIPTION**

We are looking for a highly motivated Manufacturing Engineer to deliver innovative medical devices into

development of these mechanical and electro-mechanical medical devices. The Engineer will work

closely with team members to develop detailed engineering specifications, device design &
development, support verification, validation, and regulatory submissions of these devices. The role of

the Engineer is to work within a cross-functional organization to utilize technologies and methodologies

that support short-cycle robust device development.

**JOB RESPONSIBILITIES**
- Reports to the Product Development team during design change and technology transfer activities

for interplant transfers and new product introduction.
- Coordinate and maintain change management process to ensure changes are reviewed with

multifunctional teams and implemented within the plant to meet requirements of the Device
Master Record.
- Develop Work Instructions and In-Process Inspection procedures
- Drive qualification / validation efforts as defined in Validation Master Plan, including qualifying

equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing
inspection activities. Provide complete, accurate, and well-organized documentation for
requirements, plans, reports, PFMEA’s, checklists, etc. in conjunction with NPI team
- Perform product and process evaluations to identify areas for improvement. Recommend solutions

to identified problems; Implement approved changes using sound engineering principles and fully
document them in compliance with QSR and ISO standards.
- Other duties as may be assigned by the Head of Engineering.

**JOB REQUIREMENTS**
- Bachelor’s degree in engineering or related field.
- Minimum 2 years of experience as an engineer in a related field.
- Working knowledge of validation, failure investigation, risk management, GR&R, auditing, quality
- assurance, and quality systems in a medical device environment.- Excellent knowledge of GMP and ISO standards.
- Must be meticulous, conscientious, customer service-oriented, a team player-learner with strong
- written and oral communication skills.- The ability to work independently in a dynamic manufacturing environment.
- Strong skills for planning, time management, organization, and presentation.
- Word, Excel, Project, statistical software computer skills.
- Ability to develop plans and effectively execute them
- Experience in developing fixtures for assembly preferred
- CNC machining or other manufacturing process knowledge is a plus.

If you are looking for challenges and have the qualities and experience to undertake this challenging

experience, present and expected salary, and notice period.



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