Device Engineer – GMP Manufacturing Support & Mechanical Testing (JP15754)

3 Key Consulting • New Albany, OH

3d • Onsite

About The Position

The Device Engineer will provide technical engineering support for material and component-related issues associated with commercial drug delivery devices and manufacturing operations. The primary focus of this role will be the triage, testing, investigation, escalation, and documentation of material-related issues identified during manufacturing or through other quality and technical support processes. The engineer will work closely with Manufacturing, Quality, Engineering, and other cross-functional partners to assess reported issues, determine appropriate testing and investigation strategies, generate and review technical data, and support timely disposition or escalation of issues. Scope includes mechanical delivery devices and associated components, including prefilled syringe systems. The qualified candidate will be part of a sustaining device engineering team supporting commercial manufacturing and product lifecycle activities. This position requires strong attention to detail, hands-on technical capabilities, and the ability to accurately document work within a GMP-regulated environment.

Requirements

• Hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods
• Proficiency in technical documentation and teamwork.
• Hands-on experience working within a GMP manufacturing environment is required, including familiarity with GMP documentation practices, manufacturing operations, and quality systems.
• Proficiency in Microsoft Office is required
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• At a minimum familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
• Demonstrates experience working in a GMP manufacturing environment and adheres to strict GMP documentation and compliance practices
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

Nice To Haves

• Experience in regulated industries, preferably biopharma, biomedical, or medical devices, is strongly preferred, though aerospace or mechanical disciplines are acceptable provided the candidate also has relevant GMP manufacturing experience.
• CAD/SolidWorks skills are a plus.
• Entry-level candidates with practical experience, such as internships within a GMP manufacturing or similarly regulated production environment, are preferred.
• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 2 years of scientific or engineering experience working in a GMP regulated manufacturing environment
• Demonstrated understanding of GMP manufacturing operations, documentation practices, deviations/change controls, and working within an established quality system
• Statistical Analysis software (Minitab or JMP)
• Strong technical writing skills
• CAD fixturing software (SolidWorks)
• Tolerance Stack-Ups (2D, 3D, RSS)
• Instron force tester using BlueHill Universal
• CT-Scanning
• Deviations and CAPAs
• Experience with design controls; including (but not limited to) verification and design transfer
• Understanding of risk assessments including hazard and probability analysis
• Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
• Ability to work independently and dynamically across functional teams
• Excellent written and verbal communication skills
• Ability to support complex workstreams under demanding timelines

Responsibilities

• Collaborate Cross-Functionally with the Various SMEs at the FDP Manufacturing Sites to Identify Device Issues and Root Causes
• Expanding Documentation of Site Capability and Control Strategies
• Ensuring Expedited communication to wider team on risks to device manufacturing
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintains combination product design history files for assigned products
• Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

Benefits

• Potential overtime

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed