Total 6 job vacancies by Biobot Surgical Pte. Ltd.

Responsibilities

· Design, testing and qualify PCBA/ module in accordance with design specification

· Work closely with peers, such as software, firmware, and mechanical engineering, to design a medical robot.

· Develop and maintain design documentation, including requirements, design documents, and test plans.

· Ensure compliance with relevant industry standards and regulations, such as FDA and ISO standards.

· Collaborate with other functional teams (mechanical design, process, software, manufacturing, and purchasing, etc.) to achieve project goals.

· Produce engineering outputs (BOM, CAD, WI etc.) for manufacturing of products.

· Navigate regulatory testing for Electrical Safety, Functional Safety, Radiated/ Conductor Emission & Immunity.

· Collaborate with product management and stakeholders to identify and prioritize new features and functionality for the robot.

Competency Requirements

· Master’s/ bachelor’s degree in electrical/ Electronic Engineering or other relevant discipline

· >5 years’ experience in product design and development, fresh graduates with keen interest in electrical design are welcome to apply.

· Strong working knowledge with microcontrollers, digital and analog circuitry design

· Strong working knowledge of firmware development

· Strong working experience in CAD software and PCB layout are preferred.

· Strong hands-on skills in debugging/ troubleshooting/ design verification are required.

· Able to work with other discipline to

· Able to provide guidance to junior engineers on development of product.

· Able to work independently, self-motivated and collaborate with peers in design team to design a product in accordance with specification.

· Experience in regulatory test is welcome.

Responsibilities

· Responsible for creation/ modification/ improvement of work instructions based on feedback from stakeholder(s).

· Responsible for building on medical robot/ controller unit/ cart.

· Ensure production quality and consistency.

· Provide feedback to development team on product improvement base on production flow.

· Maintain production documents.

· Analyze production process and propose production improvement plan.

· Troubleshoot production discrepancy/ variance.

· Conduct in-process verification on modular and system level.

· Program controller units

Competency Requirements

· Responsible for creation/ modification/ improvement of work instructions based on feedback from stakeholder(s).

· Responsible for building on medical robot/ controller unit/ cart.

· Ensure production quality and consistency.

· Provide feedback to development team on product improvement base on production flow.

· Maintain production documents.

· Analyze production process and propose production improvement plan.

· Troubleshoot production discrepancy/ variance.

· Conduct in-process verification on modular and system level.

· Program controller units

Job Description – Senior Regulatory Affairs Executive

• Drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards , specifically EU MDR 2017/745
• Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification (eg US FDA, SG HSA, AUS TGA etc)
• Ensure compliance with applicable regulatory requirements and standards for medical device.
• Work closely with internal team for documentation and information gathering.
• Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.
• Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.
• Participate in internal / external audits as part of the audit team (including supplier audit)
• Maintain up-to-date knowledge of regulatory requirements and changes
• Ensure post-market surveillance obligations are complied with regulations
• Any other ad-hoc assigned

Qualification Requirement

• Bachelor’s degree in biological science, biological engineering, pharmacy or related field;
• 4-5 years of experience in medical device regulatory affairs with experience in FDA 510(k) or CE marking
• Familiar with relevant regulatory guidelines and standards such as ISO 13485, EU MDR 2017/745
• Strong attention to detail and organization skills;
• Ability to work independently and as part of a team;
• Strong problem-solving and analytical skills;
• Excellent written and verbal communication skills

Job Description – Regulatory Affairs Executive

· Ensure compliance with applicable regulatory requirements and standards for medical device.

· Assist in the drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards.

· Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification.

· Work closely with internal team for documentation and information gathering.

· Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.

· Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.

· Participate in internal / external audits as part of the audit team (including supplier audit)

· Maintain up-to-date knowledge of regulatory requirements and changes

· Ensure post-market surveillance obligations are complied with regulations

· Any other ad-hoc assigned

Qualification Requirement

• Bachelor’s degree in biological science, biological engineering, pharmacy or related field;
• Preferred 2 to 3 years of experience in regulatory affairs within medical device , pharmaceutical or biotechnology industry;
• Familiar with relevant regulatory guidelines and standards eg ISO 13485;
• Strong attention to detail and organization skills;
• Ability to work independently and as part of a team;
• Strong problem-solving and analytical skills;
• Excellent written and verbal communication skills

Mechanical Engineer – Job Description

Duties and responsibilities:

As a Mechanical / Senior Mechanical Engineer you are require to perform

the following:

• Design of parts and assemblies
• Assembly of parts and sub-assemblies.
• Conduct verification & validation of design following up with reports.
• Cross functions support.
• Support production

Qualifications and Skills

• B.Eng in Mechanical Engineering
• Min 4 years experience in Product Design
• Min 4 years experience in using CAD software (Preferably Solid Works)
• Good assembly and dis-assembly skills

Other requirements

• Good knowledge of fabrication process (metal & plastics).
• Skillful hands-on skills in assembly and disassembly of products
• Conduct regular testing of subsystem under his/her responsibilities.

Software Engineer – Job Description

• Duties and responsibilities:Involved in design and development of requirements that improve on our software UroX suite.
  Maintenance and improvement of software code that are developed by third-party vendors.
  Any other software development tasks assigned
  Document software designs and code changes.
  Examples of work:
  3D visualization.
  Develop algorithms making use of artificial intelligence.
  Image processing, including image segmentation, multi-planar reconstruction, fusion of MRI with ultrasound, pattern recognition, and visual overlays
  Robotic control of a programmable electro-mechanical system
  User interface design
  Handle data connectivity e.g. to PACS / hospital networks, with considerations of cybersecurity
  Compliance with relevant regulatory standards such as IEC 62304 – medical device software – software life cycle processes
  

Software Qualifications and Skills

• Bachelor’s and/or Master’s degree in Computer Science, Computer Engineering or related technical discipline.
• At least 3 years of working experience in the related area.
• Proficiency in C++.
• Experience in Qt, Vtk, C# and Python will be an added advantage.
• Strong background in mathematics.
• Experience in image analysis, algorithm design 3D visualization, AI techniques, machine learning, computer vision algorithms will be an advantage.

Other requirements

• Good communication skills and can work well with others.
• Fast learner and independent personality.