Senior Process Development Engineer

Halyard Health Irvine, CA
Job Description Summary

We are currently recruiting for a Senior Process Development Engineer in our Irvine, CA office.

Job Description

The Senior Process Development Engineer at Avanos Medical will report to the Manager of Advanced Process Development R&D responsible for the medical devices business. They will be responsible for design, development, and commercialization of processes and equipment for existing products and other new medical devices. They will work with project teams and leaders to create/redefine product specifications through innovative and robust processing solutions. They will also be responsible for test development, protocols and reports related to verification and validation device testing. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States.

Responsibilities

* Provide technical leadership on new medical devices, by designing and developing manufacturing processes and related fixtures and tooling that are consistent with low defect levels and low product cost.

* Be the subject matter expert (SME) on any given project, and act as project lead to provide updates when the project leader is unavailable.

* Conferring with vendors in determining product specifications and arranging equipment, parts, or material purchase, and evaluating products according to quality standards and specifications.

* Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.

* Working closely with the local manufacturing department to develop, coordinate, and implement technical training for employees.

* Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&E and quality assurance functions.

* Supporting company policies and procedures, goals and objectives, FDA regulations, and goods manufacturing practices.

* Research and purchase new manufacturing technology, work in collaboration with the local engineering department to better production equipment functionality.

* Implement the transition of new technology to make sure production continues successfully without any delays.

* Act as a mentor to junior engineers within the Process Development Group.

Requirements

* Bachelor's Degree or advanced degree in Industrial, Manufacturing, Mechanical or Electrical Engineering (or similar).

* A minimum of 5+ years' experience in manufacturing and design of electronics/electronic manufacturing.

* Strong experience using manufacturing analysis tools; such as but not limited to, DOE, process capability studies, Six Sigma, etc.

* Familiar with writing validation protocols, execution and thereafter data analysis.

* Performed design transfers of new products from initial concept through launch.

* Experience with working with external service providers.

* Knowledge of engineering principles, scientific analysis, and project management.

* Must be a good communicator-written and verbal.

* Comfortable with giving technical presentations within and outside of Avanos Medical.

* Ability to prioritize multiple projects.

* Must be able to work in a team environment and meet deadlines.

* Willing to travel 25-50% at times.

Preferred

* Master's Degree in Engineering.

* Experience in medical device manufacturing assembly processes including but not limited to RF tipping equipment, Pad printing, UV/Thermal adhesive dispensers, vision systems and leak testing equipment.

* Experience with printed circuit board manufacturing equipment and processes

* Bonding fine gauge wire or flexible circuits to different substrates

* Micro-machining of metal and plastic

* Experience with Design for Manufacturability (DFM) or Design for Manufacturability & Assembly (DFMA).

* Knowledge of polymer processing techniques.

* Strong knowledge and background in mechanical and electrical engineering.

* Green Belt in Six Sigma Lean Principles (Black Belt a plus).

* Working knowledge of solid modeling (Solid Works preferred).

* A second language (Spanish would be an advantage).

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

If you are a current employee of Avanos or Halyard Health, please apply here.

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