Manufacturing Process Engineer II | Medical Device Lean & DOE

Planet Pharma; Chicopee (MA); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in Chicopee, MA, seeks a Manufacturing Engineer to develop and optimize manufacturing processes for medical devices. You will design floor layouts, validate processes, and collaborate with R&D to capture design intent for manufacturability.

You will perform DOE, DFMs, DFMEA, and coordinate with suppliers and production teams to improve cost, cycle time, and product quality in a fast-paced environment.

Qualifications

• Bachelor degree required; suitable majors listed.
• 5-7 years related work experience in medical device manufacturing preferred.
• Experience with DFM, DOE, FMEA.
• Proficient with CAD (SolidWorks, AutoCAD).
• Strong communication and teamwork.

Responsibilities

• Create documentation to support new and improved manufacturing processes
• Write and perform process validations
• Disposition NCRs and CAPAs as assigned
• Perform IQ/OQ/PQ on equipment
• Interface with assemblers, production supervisors, leads, engineers, and management
• Coordinate with suppliers for new processes
• Ensure compliance with FDA, GMP/MDD, ISO.

Skills

DFM

DOE

FMEA

CAD

Lean manufacturing

Cleanroom (CER)

MS Office

Quality compliance

Communication skills

Multi-tasking

Education

Biomedical Engineer

Chemical Engineer

Mechanical Engineer

Tools

SolidWorks

AutoCAD

MS Project

Excel

Job description

Planet Pharma in Chicopee, MA, seeks a Manufacturing Engineer to develop and optimize manufacturing processes for medical devices. You will design floor layouts, validate processes, and collaborate with R&D to capture design intent for manufacturability.

You will perform DOE, DFMs, DFMEA, and coordinate with suppliers and production teams to improve cost, cycle time, and product quality in a fast-paced environment.