Senior Medical Device Process & Validation Engineer

ADP, Inc.; Westminster (CO); On-site; USD 115,000 - 125,000; Full time

Job summary

ADP, Inc. in Westminster, CO is seeking a Sr. Manufacturing/Process Engineer to lead development, validation, and continuous improvement of manufacturing processes for medical device products, ensuring compliance with FDA QSR and ISO 13485.

The role requires directing cross-functional projects from concept through launch, validating new processes and equipment, and applying DOE, SPC, MSA, and DFM to optimize performance.

Qualifications

• BS in Mechanical or Biomedical Engineering or related field.
• 10+ years in medical device manufacturing with FDA-regulated work.
• Experience leading IQ/OQ/PQ validations and process development.

Responsibilities

• Lead development and validation of manufacturing processes for medical devices.
• Manage cross-functional projects from concept to launch.
• Develop and validate new equipment and processes (IQ/OQ/PQ).
• Apply DOE, SPC, MSA and process capability analyses.

Skills

DOE

SPC

Gage R&R

DFM

Lean

CAPA

Project mgmt

Education

BS Mechanical Eng

Job description

ADP, Inc. in Westminster, CO is seeking a Sr. Manufacturing/Process Engineer to lead development, validation, and continuous improvement of manufacturing processes for medical device products, ensuring compliance with FDA QSR and ISO 13485.

The role requires directing cross-functional projects from concept through launch, validating new processes and equipment, and applying DOE, SPC, MSA, and DFM to optimize performance.