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New Product Introduction

4 months ago

Irvine, California, United States Planet Innovation Full time

Planet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients include many of the world's top medical device companies, as well as some of the world's most exciting medtech start-ups.

With HQ in Australia and the majority of its customers in the US, PI established a world-class manufacturing facility in Irvine, California in 2021 and this division is growing rapidly on the back of high demand for our production services by both existing and new clients.

PI has an authentic, transparent, supportive culture and we offer a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.

As part of our continuous growth, we are looking for a New Product Introduction (NPI) Engineer with demonstrated experience in medical device manufacturing to join our growing team.

Reporting to the Vice President, Engineering as an NPI Engineer, you are responsible for:

The Role

  • Supporting projects to establish manufacturing and improve existing production processes for a range of technically complex products (both medical and non-medical devices).
  • Focusing on project management, client and internal stakeholder communication, as well as understanding the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner.
  • This is an onsite position.

The Accountabilities

  • Drive the establishment of manufacturing and processes for new products.
  • Support initiatives to improve the manufacturing process of new and existing products with a focus on lean assembly.
  • Preparation of dashboards and reports of key metrics.
  • Communication with clients and managing client's expectations.
  • Development of task plans, schedules and improvements for review and approval by Manager.
  • Reporting of progress and status of agreed forecasts, plans and agreed outcomes internally and to customers.
  • Ownership of product drawings, process flow charts, risk assessments, part criticality lists, BOM management, supplier establishment and qualification, technical specifications, test fixture assembly, and test tool assessments etc.
  • IQ, OQ and PQ, line validations on transfer products.
  • Responsible for product and process change management in conformance with the PI QMS (ECR/ECO).
  • EOL assessments, Equivalence studies (including verification plans and activities)
  • Management of materials non-conformances and supplier improvements with the PI QMS.
  • Responsible for driving RCA and implementation of CA and/or PA within the CAPA system.
  • Ensuring compliance with ISO 13485 / ISO 9001 (QMS and Manufacturing standards).

The Typical Experiences

  • Bachelor's degree in engineering or a related area of study and 3+ years of previous experience or equivalent.
  • Demonstrated experience in new product establishment; transferring products from design to manufacturing through a systematic transfer process.
  • Experience in change management and process improvement.
  • Exceptional interpersonal, communication, and time management skills.
  • Proven ability to work creatively and analytically in a problem-solving environment.
  • Highly organized with acute attention to detail.
  • Demonstrated ability to own tasks to meet deadlines and stay within budget.
  • Strong team orientation and cross functional attitude.
  • Experience working to policies; procedures and international quality standards, including ISO13485, ISO9001, or in a highly regulated industry.

To Apply

A positive, high-achieving work culture, and plenty of opportunities to learn and grow await you at Planet Innovation, so apply now.

We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.

Please note only applications with the right to live and work in the US will be considered for these positions.

No recruitment agencies, please.