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Product Development Specialist At AMD Medicom Inc.

Location: Pointe-Claire, Quebec

Job Description

JOB SUMMARY:

Manage product development testing proposed for product changes and improvements for the eventual inclusion in the Medicom product offering. Coordinating the testing with third party facilities and/or the manufacturing sites. Ensuring the on-time delivery of results and documentation needed to develop products.


Education & Training :

REQUIRED: University degree in engineering or the sciences

ASSET: Bachelors degree


EXPERIENCE / EXPERIENCE:

REQUIRED: Minimum of 2 years of related work experience in medical device industry with product knowledge

ASSET: Experience in with 510k product regulations and requirements.


Skills, Knowledge & Abilities:

  • Basic understanding of design controls
  • Knowledge of FDA, ISO and Health Canada regulations
  • Strong written and oral communication skills
  • Ability to lead multiple projects within aggressive timelines and multiple deliverables

Responsibility:

  • Technical lead
    • Utilize understanding of Design Control Procedures to support projects from concept to launch including prototyping, testing, and scale-up.
    • Develop documentation and ensure proper deliverable follow up as per outlined Design Control Standard Operating Procedure.
    • Create and maintain technical product specifications for new products or product improvements.
    • Provide technical Product Development support to Manufacturing, Customer Service, Regulatory, Quality Assurance, Sales and Marketing and Supply Chain.

Transfer launched product knowledge to Marketing and Regulatory.

  • Contribute to strategic sourcing activities
    • Contribute to technical testing and analysis of cost reduction alternatives for existing products under general guidance of the Director, Product Innovation and Development.
    • Provide and support the technical needs of global sourcing and manufacturing activities towards cost saving initiatives.
  • Develop and maintain risk management files as required for medical devices in particular 510k owned products.
    • Support risk management analysis and documentation for new products.
    • Ensure compliance of the brand and private label product artworks with current product and regulatory requirements and claim verification.
    • Perform 510k product complaint trend analysis and present to Manufacturing sites to effectively improve products and complement risk management process.