Hybrid Manufacturing Engineer II — Process & Quality Impact

NOVA Biomedical GmbH; Waltham, Northern (MA, KY); Híbrido; USD 90.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k match

Bonus program

Generous PTO

Hybrid work

Professional development

Office cafeteria

Descripción de la vacante

Nova Biomedical seeks a Manufacturing Engineer II to support consumable manufacturing—reagent, sensor, and tubing processes. The role resolves production issues, implements improvements, and supports transfers with cross‑functional teams to enhance safety, quality, delivery, and cost.

The ideal candidate has a mechanical/manufacturing engineering degree and 3+ years in manufacturing, with experience in documentation, validation, and risk management. Hybrid work available; salary range $90k–$105k.

Formación

• Bachelor’s degree in Mechanical or Manufacturing Engineering is required.
• 3+ years of manufacturing/engineering experience.
• Experience with validated documentation, change control, and compliance processes.
• Familiarity with FDA QSR and ISO 13485 preferred.
• Six Sigma Yellow Belt preferred.

Responsabilidades

• Provide day-to-day engineering support for consumable manufacturing processes and equipment.
• Lead or support root-cause investigations and implement corrective actions.
• Plan and execute engineering projects with defined scope, schedule, and budget.
• Represent Manufacturing Engineering on cross-functional teams and coordinate with QA/R&D/Supply Chain.
• Prepare and revise manufacturing documentation including SOPs, change orders, and validation reports.
• Support IQ/OQ/PQ protocols; analyze results and document deviations.
• Develop tooling, fixtures, and process aids; document designs and risks.
• Support new-product introduction and process transfer, including pilot builds.
• Lead continuous-improvement projects using Lean and Six Sigma methods to improve yield and cycle time.
• Perform other duties as assigned.

Conocimientos

Root cause analysis

Lean methods

Six Sigma

Cross-functional collaboration

Project management

Educación

Bachelor’s degree in Mechanical/Manufacturing Engineering

Herramientas

SolidWorks

Minitab

SAP

MasterControl

Excel

Descripción del empleo

Nova Biomedical seeks a Manufacturing Engineer II to support consumable manufacturing—reagent, sensor, and tubing processes. The role resolves production issues, implements improvements, and supports transfers with cross‑functional teams to enhance safety, quality, delivery, and cost.

The ideal candidate has a mechanical/manufacturing engineering degree and 3+ years in manufacturing, with experience in documentation, validation, and risk management. Hybrid work available; salary range $90k–$105k.