Senior Principal Engineer – Pharma/Medical Device

Inteldot; New Albany (OH); On-site; USD 120,000 - 180,000; Part time

Job summary

Inteldot is seeking a Principal Engineer to craft detailed engineering specs and support characterization testing for pharmaceutical projects in Ohio. The role requires developing protocols and validation plans, and coordinating with Operations, Engineering and Automation teams.

You will review design documents, perform risk assessments, mentor junior engineers, and ensure compliance with 21 CFR 820, ISO 14971, and EU medical device requirements.

Qualifications

• BS in Engineering; pharma/medical device sector preferred.
• 10 years of relevant experience in engineering processes.
• Led projects from development through PPQ.
• Strong background in engineering for combination products.

Responsibilities

• Develop engineering specifications and validation plans.
• Support characterization testing and protocol development.
• Coordinate cross-functional teams across operations, engineering and automation.
• Prepare and review design documents, DOE, IQ/OQ/PQ.
• Provide technical mentorship to junior engineers.

Skills

Engineering leadership

Cross-functional collaboration

DOE / SPC

Risk assessment

FMEA

Documentation writing

Regulatory knowledge

Multiphase project management

Education

BS in Engineering

Job description

Inteldot is seeking a Principal Engineer to craft detailed engineering specs and support characterization testing for pharmaceutical projects in Ohio. The role requires developing protocols and validation plans, and coordinating with Operations, Engineering and Automation teams.

You will review design documents, perform risk assessments, mentor junior engineers, and ensure compliance with 21 CFR 820, ISO 14971, and EU medical device requirements.