Principal Manufacturing Engineer

Third Pole is on a mission to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making it accessible to millions of respiratory challenged newborns and adults around the world. This is a rare opportunity to be part of a rapidly growing team, making a huge social impact, touching the lives of those we love and care about most.

We are a fast-paced startup developing a game-changing technology that generates Nitric Oxide on demand, at the patient location, from the air we breathe. Our Third Pole community is grounded in the values of collaboration, embracing diverse ideas, commitment, and transparency without the politics found in most companies. Our motto is we are only successful if we all cross the finish line together! Sound like you?

The Principal Manufacturing Engineer is a key contributor to design and development of manufacturing processes and procedures in collaboration with the chosen contract manufacturers of the Third pole products. Responsible for engineering support for New Product Introduction (NPI), including development of manufacturing assembly & test processes, tools, inspection methods, and supplier development.

The successful candidate will be part of a cross-functional team developing best practices for manufacturing processes and will help to develop, establish, and maintain methodologies, systems, and practices within Third Pole’s quality management system.

Responsibilities

• Design, develop and document manufacturing processes for new products, product changes and enhancements, and related tools, fixtures, and material handling systems; write and maintain manufacturing plans, procedures, bills of materials, and process FMEAs.
• Provide direct manufacturing engineering support for product characterization, and product builds at prototype, verification, validation, and commercial manufacturing stages, in compliance with FDA, GMP and ISO requirements.
• Interface with design engineering during new product development or product enhancement projects to assure design for manufacturability, assembly & test.
• Own and support the implementation of effective manufacturing process instructions and controls, statistical analyses, and metrics to assure products meet quality and business objectives.
• Provide technical guidance to suppliers regarding product/process compliance with engineering drawings, technical requirements & component specifications.
• Function as the lead technical liaison with contract manufacturers and suppliers. Represent manufacturing in all internal quality processes including CAPA systems, non-conformances, complaints, and internal and external quality audits.
• Apply systematic problem-solving methods for identifying, prioritizing, communicating, and driving resolution of manufacturing & quality issues using CAPA systems; initiate engineering change requests, and review/approve engineering change orders.
• Foster a continuous improvement culture using Lean and other tools/techniques to improve manufacturing, quality and business systems, processes, & tools.
• Partner with quality engineering and suppliers to ensure corrective action or problem resolution with respect to quality, cost and delivery targets, and overall efficiencies.
• Partner with QA team and Suppliers to ensure corrective action or problem resolution, delivery reliability, and parts acceptability in cost & quality aspects.
• Support supplier development and management through the supplier approval process, quality plan implementation, performance monitoring and quality audits.
• Perform other duties as needed and assigned.

  Requirements

• Bachelor’s degree in Manufacturing, Industrial Engineering, or related field; Master’s degree preferred.
• 10+ years of related manufacturing experience in the medical device industry.
• Experience with the design and/or manufacturing of complex electro-mechanical products required; familiarity with complex pneumatics strongly preferred.
• Proven record of working in FDA QSR & ISO13485 regulated environments; FMEA and process verification and validation experience required.
• Proven record of performing process verification and validation, developing & validating test methods, and transferring products into manufacturing.
• Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke.
• MS Office suite proficiency required; Visio, Access & Project preferred.
• Prior ERP/PLM and EDMS systems usage desired.
• Lean and/or Six Sigma Black Belt certification, familiarity with SolidWorks or OnShape, proficiency with Minitab or other statis