
Manufacturing Engineer
5 days ago
**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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