Total 3 job vacancies by Jobee Pte. Ltd.

1.      Responsible for the process development and validation of medical device assembly & component manufacturing processes

2.      Establish validation standards, develop master validation plan and complete all necessary validation documentation

3.      Generate IQ, OQ,PQ Protocol Document

4.      Evaluate manufacturing processes and formulate process work instructions for process validations & production.

5.      Assist to develop process parameters using tools such as Design of Experiments and engineering study

6.      Work with cross-functional team to ensure smooth delivery of medical device process validations

7.      Able to apply continuous improvement best practices tools like Lean, DMAIC or Value Stream Mapping to improve the manufacturing processes

8.      Ensure manufacturing processes are running according to specifications and incompliance with quality objectives & regulatory requirements

9.      Able to identify& help to resolve project issues  and conflicts within the project team

10.   Any other duties as assigned

Diploma / Degree in Mechanical Engineering

-         experience in process development andvalidation

-         experience in statistical analysis

-         Experience in polymer processes (injection molding, blow molding, extrusion, LSR)  and assembly processes

-         Good interpersonal skills in order to work with cross-functional teams

-         Experience with Medical Device Directive(MDD), ISO 13485, FDA design controls or similar regulatory environment

-         Experience in Medical Device with practical knowledge of manufacturing & engineering SOP’s in a regulated environment(FDA 21 CFR Part 820 or equivalent)

Security Consultant for Singapore with broad standard skills in Pentesting and strong mobile testing focus as follows:

General

• Between 2 and 6 years experience
• Annual target salary, incl. standard bonus categories: between 110,000 and 140,000 SGD
• Local Singapore, PR or existing workpass / on-site Singapore

Skills

• OSCP, CRT, CCT, other offensive security certificates
• Strong experience performing compliance testing of mobile applications that meet certain Technology Security Standards and regulatory/industries requirements : eg. MAS TRM, OWASP MSTG.
• In-depth knowledge of iOS / Android architecture and their underlying security mechanisms.
• Experienced with performing secure code review of Swift / Kotlin / Objective-C and Java applications.
• Proficient with various reverse engineering tools such as IDA Pro, Ghidra, as well as Frida.re hooking framework or equivalent.
• Knowledge of ARM architectures (armeabi-v7a, arm64-v8a, etc.) as plus.
• Ideal candidate will also have experience bypassing various security mechanisms commonly present in mobile applications (SSL pinning, root/jailbreak detection, anti-tampering, in-app VPN, etc.).
• Ability to develop BURP extensions to aid with mobile and web application tests.
• Web Applications Pentest
• Source Code Review
• Infrastructure Pentests

Job Responsibilities:

• Overall responsibility for the execution, validation and commercialization of all projects within the company.

• Overall responsibility for the assembly process setup and process development for new product introduction (NPI) projects.

• Manage the projects’ day-to-day activities to deliver projects on time, on budget, in compliance with the required standards/regulations, and meeting customers' expectations.

• Provide technical support to the production team as required.

• Liaise with customers on all matters related to the successful commercialization of all projects.

• Coordinate and work with other internal departments to facilitate a smooth flow of activities for achieving the project’s objectives and milestones.

• Conduct regular project team meetings to review and track project progress.

• Compile and communicate project summary with management.

• Provide technical support to continuous improvement (CI) activities.

• Perform any other duties as assigned.

Requirements:

• A diploma or degree in related engineering.

• More than 5 years of industrial technical experience, including project management.

• Knowledge and experience in plastic injection molding, extrusion and assembly processes used in medical device manufacturing

• Exposure to manufacturing processes validation and sterilization process.

• Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment

• Effective leadership with good communication, presentation, analytical, interpersonal and problem-solving skills.