Mechanical Design Engineer

Mechanical Design Engineer

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 Solid Works 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 Solid Works 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 building strong medical device new product development credentials and contributing to high-impact, life-saving technologies.

Work Environment

This position is based onsite in Golden, CO in an office-focused engineering environment with access to small-scale prototyping capabilities. You will work closely with external contract manufacturers to support scale production and transfer of designs into manufacturing. The role involves regular interaction with cross-functional teams, including Engineering, Quality, Clinical, and Customer-focused groups, in a collaborative setting that emphasizes clear communication, shared decision-making, and long-term product expansion supported by strong funding and strategic backing.

Job Type & Location

This is a Contract to Hire position based out…