Principal Process/NPI Engineer
Galway

€80-€85k
Full Time
Principal Process/NPI Engineer
Role Overview
GxP are excited to be collaborating with an innovative clinical phase MedTech Therapy Company dedicated to improving outcomes for patients suffering with acute decompensated heart failure (ADHF). The company is a fast growing and dynamic organisation with an extensive research, development and clinical program planned.

Core Role

  • Reporting to the VP of Technical Operations and working closely with quality, regulatory and R&D to deliver operations milestones for the business.
  • Deliver strategic objectives for technical operations that are aligned with the business strategy.
  • Manage technical operations risks in the business and promote the disciplines of risk management, systematic planning, right-first time and engineered for quality.
  • Manage an operations model that combines component & subassembly outsourcing with final assembly manufacturing. In doing so you shall (i) meet internal and external product demand, (ii) drive towards high yields following new product introductions, (iii) provide leverage and flexibility in the company's drive to reduce COGs, (iv) enable the company to provide repeatable and robust products of the highest quality, (v) protect the company's IP and (vi) allow the seamless transfer of new products from R&D to production.


Responsibilities

  • Manage the transition of new products from R&D to production.
  • Be a primary point of contact for key manufacturing partners and manage relationships with these key partners.
  • Ensure that high quality and reliable product is delivered, that supply chain runs smoothly and efficiently, that pricing is competitive, that supplier power is managed.
  • Ensure (with the support of the VP of Technical Operations) that design for manufacturing (DFM) principles are integrated into all product development projects of the company at an early stage of their development. Provide guidance, analytics, and direction on manufacturing methods, processing technology, process design, process control, takt times, product and process specifications to project teams.
  • Support the selection and development of outsourced and insourced manufacturing  operations.
  • Manage the development of new manufacturing capabilities including specification, acquisition, installation and commissioning of key process equipment.
  • Manage process characterization and process validation.
  • Manage programs to scale the technical operations of the business based on the stage of development of the business.


Qualifications, Knowledge, Skills and Experience required
  • Bachelor's degree in Mechanical, Biomedical, Electrical, Materials or Industrial Engineering. Masters or PhD in a related field is highly desirable, or an equivalent combination of education and technical experience.
  • At least 10 years of experience in the medical device industry and at least 5 years people management and leadership experience.
  • Ability to lead and motivate a team.
  • A track record of supporting new products through development, and leading commercialization operations and scaling to meet global demand.
  • Blends planning, analysis, innovation & execution to produce outstanding business results.