Manufacturing Engineer

TechDigital Group; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

TechDigital Group in Pleasanton, CA is seeking a skilled manufacturing professional with 3–4 years in medical device manufacturing. The role requires hands-on Windchill activity, BOM updates, configuration management, and MES documentation updates to support compliant production processes.

Ideal candidates will have PFMEA experience and proficiency with Minitab for statistical analysis, plus strong communication skills to collaborate across teams.

Qualifications

• 3–4 years of medical device manufacturing experience.
• Strong experience creating parts in Windchill, BOM creation/update, configuration management, procedure updates, and MES documentation updates.
• Experience with PTC Windchill and any MES system.
• Basic experience in process development, process characterization, process validation IQ/OQ/PQ.
• Experience in PFMEA.
• Knowledge of statistical analysis using Minitab.
• Good communication skills.

Skills

Medical device manufacturing

Windchill use

BOM creation/update

Configuration management

MES documentation updates

PFMEA

Statistical analysis (Minitab)

Process development basics

Communication skills

Tools

PTC Windchill

MES system

Job description

Must have Class III medical device, catheter experience

• 3 to 4 years of medical device Manufacturing experience
• Strong experience in part creation in Windchill, BOM creation/update, Configuration management, procedure update and MES doc updates
• Experience in working with PTC Windchill and any MES system
• Basic Experience in process development, process characterization, Process Validation - IQ, OQ, PQ
• Experience in PFMEA
• Knowledge in Statistical analysis using Minitab
• Good communication skills