Medical Device Engineer

ACL Digital; New Albany (OH); On-site; USD 85,000 - 125,000; Full time

Job summary

ACL Digital is seeking a Device Engineer in Ohio to provide hands-on engineering support for drug delivery devices in a GMP setting. The role emphasizes material- and component-related problem triage, testing, investigation, escalation, and meticulous documentation within a regulated environment.

You will collaborate with Manufacturing, Quality, and Engineering to determine testing strategies, generate data, and ensure timely disposition of issues, supporting product lifecycle activities and

Qualifications

• Experience in GMP manufacturing environment with strict documentation practices.
• Strong technical writing and clear communication across cross-functional teams.
• Familiarity with design controls, verifications, and change controls.

Responsibilities

• Provide engineering support for material- and component-related issues in drug delivery devices.
• Triage, test, investigate, and document issues in a GMP context.
• Coordinate lab testing for characterization, verification, design transfer, and fill-finish efforts.
• Develop and maintain device design history files for assigned products.
• Generate and review technical data, protocols, and reports.

Skills

Strong Communication

Experience in a GMP Manufacturing Envi

Strong Technical Writing

Education

Bachelor’s Degree in Mechanical, Biomedical, or related field

Tools

SolidWorks

Minitab

JMP

Instron BlueHill Universal

CT-Scanning

Job description

Working Hours: Standard shift 8-5pm potential for OT.

Ideal Candidate: has hands‑on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as 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. 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. Proficiency in Microsoft Office is required, and 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.

Top 3 Must Have Skill Sets:

• Strong Communication
• Experience in a GMP Manufacturing Environment
• Strong Technical Writing

Soft skills that need to be screened for: Looking for a self starter, someone who is ambitious

Job Description

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.

Essential Skills and 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

At a minimum familiar with the following standards and regulations:

• Quality System Regulation – 21CFR820
• EU Medical Device requirements – Council Directive 93/42/EEC

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

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