Job Title: Manufacturing Process Engineer

Location: New Richmond, WI (Hybrid)

Duration: 6 months contract with possibility of extension

SUMMARY

The Senior Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.

The candidate has in depth experience in high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within device development programs. This includes engaging internal partners and external design/development/manufacturing partners and component suppliers.

The Senior Process Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance to and coordinate work activities of other personnel. The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.

JOB RESPONSIBILITIES

The incumbent in this position will be responsible for providing design, development, and commercialization support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics. The candidate will work independently without appreciable direction from project teams or functional management. The work is reviewed upon completion. This objective will be accomplished by executing activities in the areas of:

PROCESS ENGINEERING

QUALITY SYSTEM COMPLIANCE

DESIGN CONTROLS

QUALIFICATIONS

Education and Industry Experience

B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.

At least 3-7 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.

In depth experience in high volume manufacturing processes and methodologies, with an emphasis in plastic molding and mechanical assembly is expected.

Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources in other countries is critical.

Experience working with control systems to be used in production and batch release.

Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.

Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.