Medical Device Engineer

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/Solid Works skills are a plus. Entry‑level candidates with practical experience, such as internships within a GMP manufacturing or similarly regulated production environment, are preferred.

• 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

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.

• 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

• Quality System Regulation – 21
  
  CFR
  820
• EU Medical Device requirements – Council Directive 93/42/EEC

• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 2 years of…