Process Development Engineer jobs in United States
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Inteldot · 8 hours ago

Process Development Engineer

positionDorado, US
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Inteldot has over 14 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes, focusing on equipment and process validation, documentation generation, and process optimization.

Information Technology & Services

Responsibilities

Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans
Design and develop in‑process and receiving inspection systems for new components and processes
Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions
Manage process development projects from concept through implementation, collaborating with cross-functional teams
Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes
Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors)

Qualification

Process validationManufacturing engineeringFDA regulationsAutomation controlsRoot-cause investigationBilingual SpanishBilingual English

Required

5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech)
Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485
Electrical and mechanical engineering background applied to automated manufacturing systems
Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification
Proficiency in DOE, FMEA, CAPA, and root‑cause investigation
Experience supporting new product introductions and process scale‑up
Demonstrate commitment to patient safety and product quality by complying with all applicable quality procedures
Ensure proper documentation discipline and supports Quality System compliance
Bilingual (Spanish and English)

Company

Inteldot

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Inteldot provides IT Services and IT Consulting.
dateFounded in 2004
location
San Juan, Puerto Rico, PR
people-size11-50 employees
web-link
https://www.inteldot.com/

Funding

Current Stage
Early Stage

Leadership Team

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Reggy Agosto
Founder & CEO
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Company data provided by crunchbase