Location: 
Sudbury
Employment Type: 
Permanent
Job ID: 
134508
Description: 

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

  • New product design, development and optimization.
  • Assist in the design and development process  
  • Ownership of Risk Management activities including FMEAs, Hazards analyses, etc.
  • Develop robust experimental designs and supervise their execution.
  • Develop test methods and fixturing to support experimentation.
  • Data analysis and reporting.
  • Support for biocompatibility and sterilization process development.
  • Troubleshooting of designs and processes for robust manufacturing.
  • Partner with manufacturing engineering, quality and operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
  • Liaise with external suppliers
  • Support company goals and objectives, policies and procedures – Good Manufacturing Practices, ISO, FDA and other international regulations.

EXPERIENCE/SKILL REQUIREMENTS:  

  • Experience in a regulated environment, desired.
  • A good working knowledge of the following areas:

Mechanical design

Design of molded components

Statistical design and treatment of data

CAD (2D & 3D)

  • An analytical approach to problem solving.
  • Adept at managing multiple tasks, task prioritization and working in a team.
  • Ability to analyze, understand and effectively communicate technical information
  • Excellent written and verbal communication skills.

EDUCATIONAL REQUIREMENTS: 

  • A BS or MS in Mechanical or Biomedical Engineering or equivalent training/experience

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