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Assembly and Service Technician

NPI Engineer

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StarFish Medical has an opening in Toronto, ON, for a New Product Introduction (NPI) Engineer who brings experience working with the complexities of product development in a regulated industry. The NPI Engineer reports to the NPI Manager, working closely with both the Manufacturing and Product Development teams to develop manufacturing processes and procedures, support design transfer, process validation and change control, all while managing the complexity of product development within the regulated medical device field. The NPI Engineer will use their leadership, collaboration skills and expertise to ensure effective  transfer of products to Manufacturing.

The successful NPI Engineer will utilize their industry knowledge and expertise to ensure an efficient and effective process is followed for final design and transfer of products to Manufacturing. Your knowledge of fabrication, assembly, tooling and materials and your proven communication and relationship building skills will enable you to thrive in the NPI Engineer role.

StarFish Medical offers the NPI Engineer:

  • The opportunity to work on cutting edge technology
  • Satisfaction of improving the quality of life for others through medical device technology
  • An organization with strong culture core values
  • A team oriented/collaborative environment
  • An award winning company culture & tight knit team
  • Profit sharing
  • Competitive compensation
  • Excellent medical benefits package
  • Monthly All-hands meetings
  • Active social committee
  • TTC/Transit subsidy in Toronto

Responsibilities of the NPI Engineer include:

  • Work professionally with both internal and external clients to support delivery of products that meet their business and regulatory objectives.
  • Develop procedures to support manufacturing process of new product.
  • Collaborate with the Product Development team to ensure manufacturability and effective design transfer of new products to commercialization.
  • Responsible for selection, installation, qualification (IQ/OQ/PQ), test method validation, and sustaining support of tooling and equipment utilized in manufacturing.
  • Provide schedule and budgetary input for new manufacturing programs.
  • Support Supply Chain team in the selection and qualification of new suppliers. Works closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met.
  • Support new product manufacturability by conducting research, feasibility testing, and process validation.
  • Support engineering prototype builds within the product development process.
  • Plan, execute, and document verification/validation/engineering testing.
  • Conduct time studies to determine accurate labor estimate for transferred products.
  • Conduct training and provide guidance and supervision for Production Technicians on assembling, testing, troubleshooting, and repair techniques of electromechanical equipment.
  • Generate and implement Nonconformance report and Engineering Change Requests.
  • Provide progress reports as required.
  • Travel between Victoria and Toronto will be required.

Qualifications and Abilities of the NPI Engineer:

  • Minimum of Bachelor degree (or equivalent) in a relevant Engineering discipline (with preference to Electrical or Electronics) or equivalent education gained through work experience.
  • 5-10 years’ experience & knowledge in Manufacturing, Test, or Process Engineering in a regulated industry.
  • Excellent communications skills, both verbal & written.
  • Strong planning, relationship building, and negotiation skills.
  • Innovative problem-solving skills and proven adaptability.
  • Demonstrated experience with and a deep understanding of the full development life cycle.
  • Previous experience working in a regulated environment (ISO 13485, FDA, etc.) and following a Quality Management System.

How To Apply:

Qualified NPI Engineer applicants are encouraged to apply through the brand new StarFish Medical Job Portal with a resume and cover letter that clearly indicates how your education and experience meet the requirements of this position.

If you experience any difficulties with the StarFish Medical Job Portal, please reach out to careers@starfishmedical.com with a subject line of “NPI Engineer Job Portal Issue”.

We thank all candidates who apply; however after initial acknowledgement, only those selected for further consideration will be contacted.

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We also seek innovative and dedicated professionals from a wide range of backgrounds to complement our fulltime team on a contracting basis. To apply, please submit a cover letter outlining your interest, availability and rate to the email address listed above.

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