Device Engineer

Crystal Equation Corporation; New Albany (OH); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Full benefits

401K

Parental leave

Job summary

Crystal Equation Corporation seeks a Device Engineer to support material and component issues in commercial drug delivery devices and manufacturing operations. The role focuses on triage, testing, investigation, escalation, and documentation within a GMP environment.

Collaborate with Manufacturing, Quality, and Engineering teams to assess issues, generate data, and ensure timely disposition or escalation. Experience with prefilling syringe systems and lifecycle activities is a plus, with

Qualifications

• Master's or Bachelor's degree required (or equivalent).
• Minimum 2 years of experience in a GMP regulated manufacturing environment.

Responsibilities

• Provide engineering support for material and component issues in drug delivery devices.
• Triage, testing, investigation, and documentation of material-related issues.
• Coordinate with Manufacturing, Quality, and Engineering to test, review data, and escalate when needed.
• Develop and review design history files, CO/DRs, and change controls.
• Support design transfer, verification, and GR&R analysis.

Skills

Strong Communication

GMP Manufacturing

Technical Writing

Education

Master's or Bachelor's degree

Tools

SolidWorks

Minitab/JMP

Job description

Engineer Top 3 Must Have Skill Sets: Strong Communication Experience in a GMP Manufacturing Environment Strong Technical Writing Red Flags: No Cross-Functional Experience No Practical Work Experience Summary: 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.

Responsibilities

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. 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.

Basic Qualifications

• 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

Preferred Qualifications

• 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

Pay range is $30 - $35 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

Promises We Make

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