Process Development Engineer 2


About this job

  • Branche: Medical devices
  • Area of expertise: Regulatory
  • Location: Maple Grove

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor

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.


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.


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Any questions remaining?

Your consultant, Max Schumacher is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Max Schumacher
Brunel USA - Minneapolis

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