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NPI Engineer

NPI Engineer

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StarFish Medical has an opening in Victoria, BC, 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 the Manufacturing and Product Development teams to develop manufacturing processes and procedures, and 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 the 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 the final design and transfer of products to Manufacturing. Your knowledge of fabrication, assembly, tooling and materials, and 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 core values.
  • A team-oriented/collaborative environment.
  • Award-winning company culture & tight-knit team.
  • Profit sharing.
  • Competitive compensation.
  • Excellent benefits package.
  • Monthly All-hands meetings.
  • 50% BC Transit cost sharing.
  • Shower facilities for midday runs or biking to work, Victoria offers Galloping Goose access close by.
  • Free parking on-site or around the premises.
  • An active social committee with events happening both during the workday and outside work hours. Some events cater to the individual, and others to their family.

Job Responsibilities

  • 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.

Education/Experience

  • 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.
  • Able to manage ambiguity with a demonstrated ability to bring order

Don’t meet every single requirement? Studies have shown that women and people of colour are less likely to apply to jobs unless they meet every qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace. If you’re excited about this role, but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles! Please apply through the StarFish Medical Portal.

We look forward to meeting you!

About StarFish Medical 

StarFish Medical is a leading North American contract product development and prototype/low volume manufacturing firm focused on the medical and bio-device spaces with an award-winning culture.  We tend to work on complex electromechanical devices across all medical specialties.  We have over 200 staff located in two main offices in Victoria and Toronto, Canada, and business development staff across the US and have been in business and growing for 23 years.  Our values include innovation, transparency, being aspirational and efficiency. Our job is to enable entrepreneurial medical device companies to improve medical care as their lean med-tech start-up partner assisting them in moving from idea to commercialization with as much founder value intact as possible.  Balancing our innovation mandate with reliable execution is a never-ending challenge.  We need to be consultative and help our clients become valuable and successful, sometimes in ways they didn’t imagine at the beginning, delivering that value in meaningful and powerful ways to them and their investors.  In addition to product development, we also supply intellectual property, regulatory, quality assurance, manufacturing transfer and optimization, supply chain and other complementary services.  We are known for innovation, technical excellence, service-oriented culture, and operational systems.

 

Contractors

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.

Co-op Students

Please see our Co-op Placements page for more information.

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