Senior Medical Device Product Engineer - End-to-End & QMS

Lancesoft; Los Angeles (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

LanceSoft seeks an experienced Product Development & Engineering Lead in Northridge, CA to steer end-to-end product development for medical devices, including design, prototyping, testing, and validation.

You will drive technical decisions, author engineering specs, collaborate with R&D, Quality, Manufacturing, and Regulatory teams, and mentor junior engineers while ensuring compliance with ISO 13485 and FDA requirements.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field or higher in Life Sciences or related discipline.
• 5-7 years of experience in Quality Assurance/Quality Systems in medical devices.
• Experience implementing or improving ISO 13485-based QMS.
• Strong knowledge of Singapore medical device regulatory requirements.
• Experience supporting GDPMDS/GDP certification projects.

Responsibilities

• Lead end-to-end product development activities including design, prototyping, testing and validation.
• Drive technical decisions and provide engineering expertise through the product lifecycle.
• Develop and review engineering specifications, design documents and technical reports.
• Identify and resolve complex engineering challenges using systematic problem solving.

Skills

V&V testing

Design Controls

PLM

ISO 13485

Regulatory knowledge

Education

Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering

Job description

LanceSoft seeks an experienced Product Development & Engineering Lead in Northridge, CA to steer end-to-end product development for medical devices, including design, prototyping, testing, and validation.

You will drive technical decisions, author engineering specs, collaborate with R&D, Quality, Manufacturing, and Regulatory teams, and mentor junior engineers while ensuring compliance with ISO 13485 and FDA requirements.