Principal Process Engineer

1 week ago

Toronto, Ontario, Canada fishRecruit Inc. Full time
About the Role

We are seeking a highly skilled Principal Process Engineer to join our team at fishRecruit Inc. as we continue to drive innovation in the medical device industry.

Key Responsibilities
  • Lead process development on high-priority projects, collaborating with cross-functional teams to deliver cutting-edge technical solutions.
  • Develop and implement new manufacturing and process technologies to support product development and transfers.
  • Apply new technologies and methodologies to optimize process design and performance, ensuring compliance with regulatory standards.
  • Evaluate process and design alternatives based on Design for Manufacturability principles, driving process innovation and optimization.
  • Establish processes based on product specifications, aligning with Unit Cost metrics and ensuring efficient production.
  • Complete process validation for new processes and products, including IQ, OQ, PQ, and PPQ.
  • Work with external vendors to specify, develop, and commission new process technologies, ensuring seamless integration.
  • Set up new manufacturing equipment and production lines, including the selection and training of process technicians and product builders.
  • Develop manufacturing processes from prototyping to full-scale production, ensuring smooth transitions.
  • Initiate and complete technical activities leading to new or improved products or processes for current and next-generation programs.
  • Identify process risk and drive mitigation strategies, ensuring a safe and healthy work environment.
Requirements
  • Master's degree or equivalent in an engineering discipline, with 9+ years of experience in manufacturing process design and optimization within a highly regulated environment.
  • Proven ability to conceptualize and deliver automated solutions as needed.
  • Experience in using Six Sigma methodology for process improvement (e.g., DMAIC) and problem-solving.
  • Advanced skills in statistical analysis and use of Minitab.
  • Strong knowledge and ability to teach Design of Experiments.
  • Demonstrated experience leading and mentoring technical teams.
  • Excellent proficiency in SolidWorks.
  • Proficiency in two or more of the following processes: laser welding, reflow technologies, braiding, coiling, laser cutting, injection molding, hydrophilic coating, and adhesive bonding.
  • Strong mechanical background with a working knowledge of metals and plastics processing.
  • Experience in training and mentoring engineers in problem-solving and process development tools.
  • Working knowledge of relevant medical device regulations and guidance (e.g., ISO).
Asset Skills
  • Previous experience in a disposable medical device manufacturing environment.
  • Expertise in the design of catheters, dilators, needles, and guidewires.
  • Experience with braiding and reflow processes.
  • Expertise in polymer/metal component design and manufacturing, including part design, injection molding, reflow, bonding/welding, heat treatments, and casting.
  • Proficiency in fixture and tooling design.
  • Experience with automated work cell and equipment design.
  • Strong background in mechanical mechanism design and analysis.
About fishRecruit Inc.

We are a leading company in the medical device industry, dedicated to improving patient care through advanced technology. Our team consists of intelligent and success-driven individuals who are passionate about making a difference.

We offer a comprehensive rewards package, including tuition reimbursement and a health spending account. Our hybrid model and flexible hours empower you to thrive both personally and professionally. Join us in our mission to drive innovation and excellence in the medical device industry.

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