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Staff NPI Manufacturing Engineer

Nicoya Lifesciences

Nicoya Lifesciences

Other Engineering
Kitchener, ON, Canada
Posted on Monday, May 29, 2023

Staff NPI Manufacturing Engineer

Location: Kitchener, Ontario

Job type: Full time, permanent

Experience: Minimum 10 years of experience

Education: BS or MS in engineering, operations, or a similar field with relative experience


About the Job:

The role will drive continuous improvement across our consumable product manufacturing lines as we scale from low/medium to high volume, and lead the transfer of new consumable products from R&D into manufacturing. You will act as the SME in lean manufacturing with a strong focus on process control, manufacturing employee training, and metric development. This is a hands-on role where you will be the point person cross-functionally for manufacturing process implementation and problem-solving.

Click here to meet our new product Alto. This role will focus primarily on the various cartridge and consumable products for Alto.

Who you are:

You have a passion for managing complex semi-automated manufacturing processes. A mission of reducing high variability in a new complex life-science manufacturing process excites you. People describe you as data-driven and a process-originated problem solver. You enjoy contributing to both high-level manufacturing strategy, and digging into the smallest details on the shop floor to understand problems, and implement solutions. You have a strong ability to find and correlate information that at first might not be apparent to drive improvements.


Specifically, your responsibilities will include:

  • Continuously monitor, measure and improve the consumables manufacturing lines with a heavy focus on process control.
  • Develop and implement manufacturing strategies, processes and metrics to improve production processes, reduce costs, and enhance product quality.
  • Work closely with the design team to ensure new products are manufacturable, then lead the transfer into manufacturing.
  • Lead a collaborative effort to identify, prioritize, and implement continuous improvement.
  • Manage BOMs in PLM.
  • Interface with equipment and material suppliers as a technical authority.
  • Contribute to evaluating the benefits and creating design requirements for increased automation.
  • Assume responsibility for pilot builds and validation from a process standpoint.
  • Lead pFMEAs and risk mitigation efforts.
  • Produce, review, and/or approve manufacturing design transfer documentation.
  • Setup, validate, troubleshoot, and schedule preventative maintenance for equipment.
  • Investigate and implement corrections for machine and product failures in manufacturing.
  • Contribute to design reviews as the voice of manufacturing for DFA/DFM.
  • Ensure the consumable manufacturing floor is in compliance with required safety regulations.

Qualifications:

  • Minimum of 10 years of manufacturing process experience
  • Expert with manufacturing tools such as Lean, Poka-yoke, Six Sigma, pFMEA
  • Expert in statistical process capability, control and analysis
  • Experienced with implementing fully or semi-automated assembly line equipment
  • Strong continuous improvement mindset
  • Experience utilizing ERP, PLM and QMS
  • Superior communication skills
  • Experience holding staff accountable to execution according to the QMS.
  • BS or MS in engineering, operations management or a similar field with relative experience

Bonus points for experience in one or more of these areas:

  • Life Sciences industry
  • cGMP or cGLP
  • Cleanrooms
  • Wet lab manufacturing
  • Small delicate mechanical assemblies
  • BarTender labelling software
  • Propel PLM/QMS systems
  • Implementing LIMS
  • Scale up business

About Us:

Nicoya’s mission is to improve human life by helping scientists succeed. We are a fast-paced, rapidly growing company based in Kitchener, Ontario - Canada's Silicon Valley, but have a world-wide presence. We have a team of world class engineers, scientists, and designers building disruptive products to help researchers make their next big discovery. Our first product, OpenSPR, is a scientific instrument for the biotechnology research and development industry. It provides detailed information on molecular interactions using optical nanosensor technology known as localized surface plasmon resonance. It is the most affordable SPR instrument on the market and has disrupted an industry that has been primarily dominated by highly expensive and complex instrumentation.

Nicoya is an inclusive and equal opportunity employer. If you require an accommodation to participate in the recruitment process, please let us know. We will accommodate your needs as required under applicable legislation. Information related to accommodation requirements will be addressed confidentially.

In your application, please include your resume along with a cover letter. While we appreciate all applications, only those candidates selected for an interview will be contacted.