Senior 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 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.

Requirements

• 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.

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.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Pay

The pay range for this position is $55.00 - $68.00/hr.

Schedule

This is a Contract to Hire, fully onsite position based in Golden, CO.