Product Development Engineer

Job Description:

• Lead, coordinate, and execute product development activities for blood management products, such as blood bags, in alignment with defined goals and targets.
• Define project scope, approach, strategy, market potential, pricing targets, and critical success factors.
• Manage project budgeting, scheduling, timelines, and cross-functional coordination with internal departments, customers, and suppliers.
• Conduct biocompatibility evaluations in compliance with ISO 10993, including biological testing, chemical characterization, risk assessments, and preparation of related documents (BEP, BER, BRA).
• Support regulatory submissions with biocompatibility sections (Technical Files, Design Dossiers, CERs) and maintain product compliance, technical files, and design history files.
• Plan and execute design verification and validation tests, including type testing and biocompatibility assessments.
• Perform biological assessments to support material changes and establish SOPs for test methodologies.
• Carry out equipment calibration and maintenance as required.
• Provide regular project updates to management and perform ad-hoc duties assigned by the Section Head.

Job Requirement:

• Degree in Biomedical Science, Material Science, Life Sciences, Manufacturing, or a related discipline.
• Minimum 2 years of experience in medical device design and development, or blood component processing (preferably in a blood bank setting).
• Proficient in Microsoft Office.
• Strong data analysis skills.
• Able to work independently and as part of a team.
• Good interpersonal and communication skills.