Manufacturing Process Engineer

MAIN PURPOSE OF THE ROLE

Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Medical Device Manufacturing Process. Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

• As the Experienced professional in the Medical Device Manufacturing Process Sub-Function, possesses well developed skills in implementing and maintaining high volume manufacturing processes.
• Serve as the primary process owner for several PCB manufacturing processes, including Solder, Epoxy Dispense, Wirebond, Underfill, Laser Processing, and Mechanical Routing.
• Establish and maintain robust, compliant, and validated processes that meet medical device manufacturing requirements.
• Develop and maintain process documentation
  , including work instructions, standard work, control plans, PFMEAs, and equipment settings.
• Conduct and document process capability analysis (Cp/Cpk) and implement actions to improve reliability and product performance.
• Own the lifecycle of process equipment: reflow ovens, dispensers, pick‑and‑place modules, wirebonders, underfill systems, lasers, mechanical routers, etc.
• Define equipment requirements, support vendor evaluations, lead installations, and oversee equipment validation (IQ/OQ/PQ).
• Collaborate with maintenance on PM schedules, calibration, uptime tracking, and tooling readiness.
• Evaluate and qualify all process materials, including solder paste, flux, epoxy/adhesives, underfill chemistries, wirebond materials, and cleaning solvents.
• Monitor daily yield, scrap, and defect trends; drive root cause investigation
  , CAPA activities, and long‑term corrective actions.
• Services, troubleshoots, and solves engineering problems with processes or equipment already in operation.
• Generate and execute process validation protocols (IQ/OQ/PQ, PPQ) in alignment with medical device regulatory expectations.
• Provide manufacturability feedback to R&D on PCB layout, component spacing, bond pad design, solder joint access, and material compatibility.

Education
Associates Degree (± 13 years)

Experience/Background
Minimum 1 year

The base pay for this position is $61,300.00 – $. In specific locations, the pay range may vary from the range posted.