Project Engineer

About the role

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific's leading medical device developer and manufacturer. We value the importance of having a robust engineering team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Project Engineer to join us on this journey. In this role, you will ensure that our pipeline's key products achieve their milestones from the design and development phase all the way to manufacturing. Your role will involve working with different departments within Vivo Surgical as well as with our external partners such as contract manufacturers, design houses and health systems. Your responsibilities shall include the following: Define project scope, timelines, budgets and deliverables. Ensure project milestones are met within timeline and budget. Coordinate cross-functional teams, track progress and manage risks. Provide technical and analytical inputs and implement mitigation strategies. Support prototyping, testing and design iterations. Involved in verification and validation test planning and formalizing results. Facilitate transition from R&D to production, emphasizing design for manufacturing (DFM) and scalability. Manage engineering and documentation changes through formal change control processes. Support risk management activities and documentation (FMEA, hazard analysis...). Prepare design history files (DHF), device master records (DMR) and technical documentation. Facilitate design reviews and ensure proper documentation and traceability through product lifecycle. Engage with external vendors, contract manufacturers and test labs. Your Qualifications & Experience Minimum Bachelor's degree in Engineering or Science. At least 3 years' experience of project management in the medical device industry or New Product Introduction (NPI) or equivalent. Knowledge of project management techniques, tools and software is a plus. Familiarity with medical device standards (ISO 13485, ISO 14971) is an advantage. Strong understanding of the medical device development lifecycle and design documentation. Experience in cross-functional collaboration (R&D, QARA, manufacturing). Proficiency in data analysis and problem-solving methodologies. Experience with design for manufacturing (DFM) and process validation is an advantage. Good communication and stakeholder management skills. Ability to manage multiple projects in a fast-paced environment. Contact Please send your CV and cover letter to: hr@vivo-surgical.com. We look forward to receiving your application.

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