Product Development Engineer

JMS Singapore Pte Ltd; Singapore; On-site; SGD 60,000 - 95,000; Full time

Job summary

A leading company in the biomedical industry is seeking a Product Development Lead to oversee the development of blood management products. The role involves coordinating projects, conducting biocompatibility evaluations, and ensuring compliance with regulatory standards while working closely with cross-functional teams. Candidates should possess a relevant degree and at least 2 years of experience in a similar role.

Qualifications

• Minimum 2 years of experience in medical device design and development.
• Experience in blood component processing, preferably in a blood bank setting.

Responsibilities

• Lead product development activities for blood management products.
• Manage project budgeting, scheduling, and cross-functional coordination.
• Conduct biocompatibility evaluations and support regulatory submissions.

Skills

Data analysis

Interpersonal skills

Communication skills

Proficiency in Microsoft Office

Education

Degree in Biomedical Science, Material Science, Life Sciences or related discipline

Job description

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