Mechanical Design Engineer

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

Job Description

Job Description

Mechanical Design Engineer

Work for a Leading Organization in the Medical Device Industry!

* *Hiring Mechanical Design Engineer (Details provided) along with a variety of other technical Engineers in this area, please inquire within if interested! * *

Job Description

This Mechanical Design Engineer role supports the development of next-generation, needle-free drug delivery systems, with a primary focus on a new pre-filled syringe application. You will lead hands‑on mechanical design, prototyping, and design controls activities from proof‑of‑concept through validation, ensuring compliance with FDA and ISO requirements. The position offers significant visibility and ownership within a growing product portfolio that has global clinical and commercial impact, including use in life‑saving drug delivery technology for worldwide health programs.

Responsibilities

• Drive new product development for needle‑free drug delivery systems, supporting the full lifecycle from proof‑of‑concept through design verification within a stage‑gate NPD process.
• Develop and refine mechanical concepts for pre‑filled syringe and disposable components, translating requirements into robust, manufacturable designs.
• Create, update, and release detailed 3D CAD models and final production drawings using SolidWorks or equivalent 3D CAD tools.
• Author, maintain, and organize Design History Files (DHF) and other design control documentation in accordance with FDA and ISO requirements.
• Support internal and external audits and inspections by providing complete, accurate design documentation and technical justification for design decisions.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to optimize designs for scale‑up and high‑volume production.
• Collaborate closely with contract manufacturers and key suppliers to ensure design intent, manufacturability, and quality are achieved in production.
• Manage prototype builds, including planning, coordinating vendor activities, and overseeing assembly and testing iterations.
• Lead or contribute to testing and validation activities, analyzing results and driving design refinements based on performance, reliability, and safety data.
• Engage with cross‑functional partners in Engineering, Quality, Clinical, and Customer functions to align design solutions with user needs, regulatory expectations, and commercial goals.
• Support design reviews, risk assessments, and DFMEA activities to identify, document, and mitigate potential failure modes in the design.
• Contribute to continuous improvement of design control processes and documentation practices within the medical device development environment.
• Provide technical input and light project leadership in vendor‑facing discussions, ensuring timelines, quality standards, and technical requirements are met.

Essential Skills

• At least 5 years of experience in mechanical design, including hands‑on work in new product development.
• Hands‑on experience designing medical devices in a regulated environment, with direct involvement in design controls and documentation.
• Proficiency in SolidWorks or equivalent 3D CAD software for creating detailed models and production‑ready drawings.
• Strong understanding of mechanical design principles for disposable, syringe‑based, or similar precision components.
• Ability to manage and execute prototyping activities, including coordinating builds, testing, and iterative design refinement.
• Experience applying Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to optimize designs for production.
• Capability to work effectively in cross‑functional teams, collaborating with quality, clinical, manufacturing, and customer‑facing partners.
• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.

Additional Skills & Qualifications

• Working knowledge of ISO and FDA design controls, including practical experience with Design History Files (DHF) supporting new product development from concept through testing.
• Experience with pre‑filled syringes, disposable medical devices, or other drug delivery systems.
• Direct exposure to FDA inspections or ISO audits, with familiarity in preparing and presenting design documentation.
• Experience with Design of Experiments (DOE) for optimizing design parameters and validating performance.
• Vendor‑facing experience and light project leadership responsibilities, such as coordinating external partners and managing deliverables.
• Interest in