Lead Mechanical Design Engineer – Needle-Free Drug Delivery

Actalent; Colorado; On-site; USD 90,000 - 120,000; Full time

Job summary

Actalent is seeking a Mechanical Design Engineer to lead hands-on design for needle-free drug delivery systems, focusing on a pre-filled syringe application. You will drive design, prototyping, and design controls from concept through validation, ensuring compliance with FDA and ISO requirements.

You will collaborate with Quality, Clinical, Manufacturing, and vendor partners to optimize manufacturability, support audits, and guide production-ready designs for global health programs.

Qualifications

• 5+ years of hands-on mechanical design in product development.
• Experience designing medical devices in regulated environments with design controls.
• Proficiency with detailed 3D CAD models and production drawings.

Responsibilities

• Drive new product development for needle‑free drug delivery systems from concept to verification.
• Develop and refine mechanical concepts for pre-filled syringe components.
• Create and issue production drawings and 3D CAD models.
• Maintain DHF and design control documentation per FDA/ISO requirements.
• Support audits with complete design documentation and justification.
• Apply DFM/ DFA to optimize for scale-up and high-volume production.
• Collaborate with contract manufacturers and suppliers to ensure design intent and manufacturability.
• Manage prototype builds and oversee testing iterations.
• Lead testing and validation activities, analyzing results for design refinements.
• Collaborate with Engineering, Quality, Clinical, and Customer teams to align with user needs and regulatory expectations.
• Contribute to design reviews and risk assessments (DFMEA) and document improvements.

Skills

Mechanical design

Medical devices

SolidWorks

Design controls

DFM DFA

Prototyping

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

Actalent is seeking a Mechanical Design Engineer to lead hands-on design for needle-free drug delivery systems, focusing on a pre-filled syringe application. You will drive design, prototyping, and design controls from concept through validation, ensuring compliance with FDA and ISO requirements.

You will collaborate with Quality, Clinical, Manufacturing, and vendor partners to optimize manufacturability, support audits, and guide production-ready designs for global health programs.