Process Engineer

Job Title: Process Engineer

Location: Hybrid remote (commutable to New Richmond, WI)

Contract Duration: 12 months (potential for full-time conversion)

Compensation: $34.53 to $61.17/hr (W2), based on experience

Executive Summary

The Process Engineer will support drug delivery device production innovation at Client. This role involves industrializing combination drug delivery devices for parenteral pharmaceutical therapeutics.

The ideal candidate has extensive experience in high-volume manufacturing processes, process development, and collaboration with internal and external manufacturing partners. They will independently manage engineering projects, define critical steps, and develop solutions to complex challenges.

Key Responsibilities

Process Engineering:

• Conduct DFM/DFA assessments and develop testing methods for device quality and functionality.
• Lead process development using state-of-the-art technology for clinical and commercial production.
• Apply statistical and modeling tools for process characterization, including DOE and Monte Carlo simulations.
• Develop, procure, and manage lab-scale clinical manufacturing equipment and assembly fixtures.
• Document clinical and commercial equipment qualifications, validation protocols, and SOPs.
• Provide technical leadership and recommend efficient assembly processes for medical devices.

Quality System Compliance:

• Implement client Pharma Quality Policy and Pharma Quality System (PQS).
• Conduct root cause analyses and support CAPA initiatives.
• Address quality issues from audits, regulatory inspections, and assessments.
• Maintain compliance through training and adherence to PQS requirements.

Design Controls:

• Oversee design transfer to commercialization, ensuring quality and compliance.
• Draft and review design control documents, including DHF and risk management plans.
• Maintain documentation using electronic archive systems and ensure compliance with DHF regulations.

Collaboration:

• Interface with internal and external stakeholders, including manufacturing, quality, and procurement teams.
• Support supplier selection and evaluation for equipment and automation development.
• Collaborate on translating design requirements into commercial processes.

Qualifications:

• Education: B.S., M.S., or advanced degree in Engineering (Mechanical Engineering preferred).
• Experience: At least 3 years in high-volume manufacturing, with a focus on plastic molding and mechanical assembly.
• Technical Skills: Proficiency with statistical tools (JMP, Minitab), Six Sigma (Green/Black Belt), and process validation techniques.
• Interpersonal Skills: Strong communication, organizational skills, and experience in cross-functional collaboration.

Training Requirements:

• Core training must be completed within the specified time from the onboarding date.