210 New Product Introduction Engineer

Kardium has a unique opportunity for an experienced New Product Introduction (NPI) Engineer. As a member of the Manufacturing Engineering team, the NPI Engineer will be responsible for smooth transfer of new or updated product designs and processes into production and for ensuring that changes are implemented in a coordinated and organized manner that meets project timelines. This position will report to the Manufacturing Engineering Team Lead.

Duties and Responsibilities

In your role as the NPI Engineer, you will be responsible for

  • Initiating Engineering Change Orders (ECO) and driving manufacturing related change control activities
  • Identifying process parameters and drafting process requirements and control plans
  • Compiling a complete list of required process equipment and fixtures and initiating all equipment IQ protocols
  • Coordinating and driving process validations, process requirements and risk review activities across multi-functional teams to ensure timely process transfer to manufacturing
  • Generating work instructions and production travellers
  • Coordinating sample builds with Planning and Manufacturing for all Process Validation (PV) activities and ensuring input part designs and build instructions are available
  • Ensuring that any issues encountered during sample build are fed back to the design team
  • Maintaining technology transfer progress dashboards and providing updates on a periodic basis
  • Continuously identifying opportunities to improve the efficiency of the technology transfer process to manufacturing

Experience and Qualifications

  • Bachelor’s degree in an engineering, technical or scientific field
  • Minimum 3 years’ experience in a technology transfer, manufacturing operations or engineering change management role in a regulated manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
  • Strong technical aptitude and ability to understand and communicate complex technical issues
  • Strong, practical knowledge of R&D, NPI, supply chain, planning and quality control

Skills and Attributes

  • Effective verbal and written communication skills
  • Excellent interpersonal skills and ability to drive decisions and work cross-functionally within an organization
  • Proven project coordination and management skills
  • Strong mechanical and electrical aptitude
  • Adept with MS Office and strong ability to swiftly come up to speed with new software tools
  • Able to operate independently with minimal direction
  • Flexible and adaptable to take on additional responsibilities as appropriate

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “210 New Product Introduction Engineer” in the subject line.

To apply for this job email your details to jobs@kardium.com