Product Development Specialist

2 days ago


Penang, Malaysia Link Compliance Full time

Link Compliance is hiring a Product Development Specialist - Medical Devices to lead the development of our innovative medical devices.

About the Role:
  • This role will be responsible for managing projects from concept to launch, ensuring timely delivery and high-quality results.
  • The specialist will collaborate with cross-functional teams, including engineering, quality, and manufacturing to develop and implement new products.
  • A key focus will be on understanding customer needs and preferences to inform product design and development.
Responsibilities:
  • Manage projects from concept to launch, ensuring timely delivery and high-quality results.
  • Collaborate with cross-functional teams to develop and implement new products.
  • Understand customer needs and preferences to inform product design and development.
  • Ensure compliance with FDA and ISO quality system regulations.
  • Work closely with quality and manufacturing teams to ensure smooth production and delivery.
  • Communicate effectively with stakeholders, including customers, engineers, and quality personnel.
  • Maintain accurate records and reports to track project progress and performance.
Qualifications:
  • Bachelor's degree or higher in Mechanical/Manufacturing Engineering or related discipline.
  • 2+ years of project management/manufacturing engineering experience in medical device industry supporting a FDA Class III medical device.
  • Experience working with/in contract manufacturing environment.
  • 'Hands-on' mechanical aptitude, engineering acumen and analytical skills
  • Ability to read and understand engineering drawings.
  • Process implementation and process validation experience.
  • Experience with software based mechanical medical devices and products.
  • Solid organizational planning, communication skills, articulate, team player, dependable, able to work in a fast-paced environment with accuracy/efficiency.


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