Process Development Engineer 2

PUB365333

medical device pharmaceutical food industry

About this role: Process Development Engineer 2

Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

Our client is looking for a Process Engineer that will participate on New Product Development projects by developing robust manufacturing processes for new products across our core portfolios. Utilizing first-principles thinking and data-driven decision-making, they will ensure these processes produce products that meet design specifications and cost targets. Responsibilities includes the planning and execution of equipment and process validation, and the transfer of these processes into production for commercial manufacturing.

Requirements

Design, characterize and implement manufacturing processes that are robust in meeting design output requirements

Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader.

Identify, specify, and coordinate development, sourcing and qualification of equipment, tooling, fixtures and component materials to produce product per design specifications.

Execute process characterization and investigations to establish process limits.Generate documentation as outlined in the Process development process (e.g., PFMEAs, protocols, reports, MPs, Design Transfer reports, etc.).

Develop and implement documented procedures to provide easy to follow instructions for production of products meeting design specifications and requirements.

Mentor and direct PD technicians to perform and document equipment qualifications, process characterization and qualification builds.

Conduct test data analysis including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determining process capability.

Investigate and troubleshoot process issues, determine causes, recommend, and implement solutions.

Conduct process design, development, and implementation on multiple projects. Coordinate, and execute systematic process development activities such as process characterization, DOE (to establish process limits), qualification and validation builds.

Accurately document characterization studies, develop validation build records, independently generate OQ and PQ protocol and report documents.

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About Brunel

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About Brunel

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Max Schumacher via the details below, quoting publication number:
PUB365333

Account manager

Max Schumacher
Brunel USA - Minneapolis
m.schumacher@brunel.net
612-430-5462

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