Process Engineer

Currently I have an opening for a Process Engineer located in New Richmond, WI (Hybrid position). Details for the position are as follows:

Job Description:

• The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery devices for parenteral pharmaceutical therapeutics.
• The candidate will work with limited direction and may provide guidance to and coordinate work activities of other personnel.
• Provide DFM/DFA assessment of container-device, and development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
• Use of state-of-the-art technology to lead process development to enable clinical and commercial production in our worldwide network.
• Extensive application of tools to assess design process capabilities such as tolerance analysis, design of experiments, design for reliability, quality by design, design for six sigma, failure modes effect analysis
• Characterize and evaluate critical process parameters (CPPs) using appropriate tools such as DOEs, components of variance, house of quality, etc., leveraging electromechanical presses and custom fixtures to run simulations in the lab.
• Characterize material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
• Support or lead evaluations and investigations applying the most appropriate root cause analysis tools and methodologies.
• Procure lab-scale clinical manufacturing equipment. Design, fabricate, and procure fixtures for device assembly and testing.
• Author / review documentation related to clinical and commercial equipment qualification activities including pFMEAs, FAT, IOQ, and PQ. Author / review process validation protocol(s) and report(s).
• Author / review SOPs for clinical/ commercial manufacturing (including labeling, packaging, preventative maintenance, and equipment operation).
• Bachelor’s or master’s degree with less than 6 years of experience within medical device supporting process engineering and mechanical engineering.

Technical Information:

• 12-month contract with potential for extension or conversion
• Pay: $40-61 hourly, depending on experience level
• Hybrid position – onsite 2-3 days a week