Process Engineer

miDiagnostics is working on the development and commercialization of a rapid real-time PCR-based quality control sterility test intended for CAR-T cell therapy products. We are seeking a hands-on and pragmatic Process Engineer to play a critical role in establishing our prototype cartridge production line. This is a unique opportunity to work at the intersection of product development, engineering, and manufacturing in a dynamic and fast-paced environment.

Initially, your focus will be to partner closely with the product development team and development partner to:

·        Set up internal, small-scale prototype cartridge manufacturing workflows.

·        Troubleshoot early-stage manufacturing issues.

·        Identify, implement and document scalable, and reproducible process solutions.

As the program matures, you will take ownership of all process engineering aspects of the cartridge lifecycle, driving tech transfer to external Contract Manufacturing Organizations (CMOs) and internal operations as appropriate, ensuring readiness for scale-up and commercialization.

Key Responsibilities

• Serve as the subject matter expert for all technical aspects related to the manufacturing processes of the sterility cartridge

• Design, implement, and optimize early-phase cartridge assembly processes in alignment with product design and functional requirements.

• Collaborate closely with product development, mechanical engineering, and assay teams to ensure design-for-manufacturability (DFM) and seamless integration of process steps.

• Define process requirements, critical parameters, and control strategies to support scalable and reproducible manufacturing

• Lead root-cause analysis and troubleshooting efforts using ‘problem solving’ techniques.

• Define and document process parameters, SOPs, and work instructions for assembly workflows.

• Develop and execute/support (in case of CMO) process validation protocols (IQ/OQ/PQ) as needed, responsible for p-FMEA.

• Plan and support scale-up activities including equipment selection, automation concepts, and layout of pilot manufacturing lines.

• Coordinate with Quality and Regulatory teams to ensure compliance with relevant standards (e.g., ISO 13485).

• Lead or support tech transfer of cartridge manufacturing processes from internal production to CMOs, ensuring successful knowledge transfer, process control, and quality assurance.

• Drive continuous improvement and cost reduction initiatives.

• Provide input in planning to the overall program (PMO)

• Master’s degree Electromechanics or Biomedical engineering, or Bachelor’s degree with relevant experience

• 5+ years of experience in process engineering or manufacturing engineering in the medical device, diagnostics, or life sciences industry.

• Knowledge of production, Process Control Tools, lean and six sigma.

• Proven hands-on experience working in controlled environments (e.g., ISO Class 8 cleanrooms), with a strong preference for experience in sterile or aseptic manufacturing settings

• Proven expertise scaling processes from early-stage development to pilot or commercial production, preferably for enclosed, multi-component diagnostic cartridges or consumables.

• Strong understanding of assembly and bounding techniques as well as reagent integration

• Experience with prototyping tools, jigs/fixtures design, and hands-on troubleshooting.

• Familiarity with GMP, ISO 13485, and FDA requirements.

• Strong project management and cross-functional collaboration skills.

• Detail-oriented, adaptable, open to changes and energized by startup-like environments.

• Thrive in a fast-paced and changing environment

• Ability to travel as required