Senior Engineer, Medical Device Product Development

Successfactors; Singapore; On-site; SGD 120,000 - 190,000; Full time

Benefits offered by this job

Entrepreneurial environment

Global teams

Professional development

Job summary

BIOTRONIK is seeking a Senior Engineer, Product Development in Singapore to contribute across the full development lifecycle. You will translate market requirements into technical specifications, lead design and verification activities, and drive the introduction of new technologies within a global R&D context.

You will collaborate with project managers and cross‑functional teams across BIOTRONIK sites, ensuring adherence to ISO13485 and GMP, and mentoring production personnel on new methods.

Qualifications

• Minimum 5 years in R&D, product development or process/production engineering, preferably medical devices.
• Experience with international regulatory approval processes for medical devices.
• Familiarity with ISO13485 and GMP requirements; quality- and design-controlled environment.
• Strong project management skills with cross-functional leadership ability.
• Hands-on engineering, testing and data analysis in a lab setting.

Responsibilities

• Oversee daily operations of the R&D Product Development group and support Head of R&D.
• Lead internal sub-product development projects; act as Sub-Project Manager Hardware Development.
• Develop products; qualify and integrate new technologies and materials per standards.
• Ensure design quality for usability, reliability, functionality and manufacturability.
• Support design verification and validation; collaborate with cross-functional teams.
• Train production personnel on new and existing methods; prepare structured reports.
• Conduct risk assessments and participate in production process risk reviews.
• Provide technical support to manufacturing, operations and product maintenance.

Skills

R&D experience

Project management

Cross-functional leadership

Regulatory knowledge

Verification & validation

Medical device experience

ISO13485 & GMP familiarity

Laboratory testing

Communication & teamwork

Education

Bachelor’s Degree in Electrical, Mechanical or Industrial Engineering

Tools

Statistical analysis

Job description

BIOTRONIK is seeking a Senior Engineer, Product Development in Singapore to contribute across the full development lifecycle. You will translate market requirements into technical specifications, lead design and verification activities, and drive the introduction of new technologies within a global R&D context.

You will collaborate with project managers and cross‑functional teams across BIOTRONIK sites, ensuring adherence to ISO13485 and GMP, and mentoring production personnel on new methods.