Job Title: Mechanical Design EngineerJob Description
The Mechanical Design Engineer will support the development of next-generation, needle-free drug delivery systems, with a primary focus on a new pre-filled syringe application. You will take ownership of mechanical concepts from proof-of-concept through validation, leading hands-on mechanical design, prototyping, and design controls activities. Working closely with quality, clinical, and manufacturing partners, you will ensure that designs comply with FDA and ISO requirements and are ready for clinical and commercial use worldwide. This is a highly visible role within a growing product portfolio, offering meaningful impact on global health and the opportunity to build strong medical device new product development credentials.
Responsibilities
Lead mechanical design activities for new needle-free drug delivery systems, with emphasis on a pre-filled syringe application.
Drive new product development from proof-of-concept through design verification, following a structured, stage-gate NPD process.
Create, refine, and release detailed 3D models and final production drawings for disposable and syringe-based components using SolidWorks or equivalent 3D CAD tools.
Author, maintain, and organize Design History Files (DHF) to support ISO and FDA design control requirements throughout the development lifecycle.
Support regulatory and quality activities, including preparation for and participation in audits and inspections related to design controls.
Apply design for manufacturability (DFM) and design for assembly (DFA) principles to optimize designs for scale-up and efficient production.
Collaborate with contract manufacturers and key suppliers to ensure designs can be reliably produced at scale and meet quality and performance requirements.
Manage proto@type builds, including planning, coordinating, and tracking proto@type iterations with internal teams and external vendors.
Conduct and support testing iterations on proto@types, analyze results, and implement design refinements based on performance and reliability data.
Work cross-functionally with engineering, quality, clinical, and customer-facing teams to align design decisions with user needs, regulatory expectations, and business objectives.
Document design decisions, risk assessments, and verification activities in accordance with ISO and FDA design control standards.
Contribute to continuous improvement of design and development processes, tools, and documentation practices within the engineering team.
Essential Skills
2-5 years of experience in mechanical design engineering, preferably in new product development.
Hands-on experience designing medical devices in a regulated environment.
Proficiency in SolidWorks or equivalent 3D CAD software for creating and updating 3D models and production drawings.
Working knowledge of ISO and FDA design controls, including authoring and maintaining Design History Files (DHF).
Experience supporting new product development from concept through testing and design verification.
Strong understanding of mechanical design principles and their application to disposable and syringe-based components.
Ability to collaborate effectively with cross-functional teams including quality, clinical, manufacturing, and customer-focused groups.
Bachelor's degree in Mechanical Engineering or a related engineering discipline.
Additional Skills & Qualifications
Experience with pre-filled syringes, disposable medical devices, or drug delivery systems.
Direct exposure to FDA inspections or ISO audits related to medical device development.
Experience with Design of Experiments (DOE) for design optimization and verification.
Vendor-facing experience, including coordinating with external suppliers or contract manufacturers.
Light project leadership experience, such as leading small workstreams or coordinating cross-functional tasks.
Interest in contributing to life-saving technologies and building long-term expertise in medical device new product development.
Work Environment
This role is based onsite in Golden, CO in an office-based engineering environment that includes access to small-scale prototyping capabilities. You will work closely with cross-functional teams, including engineering, quality, clinical, and customer-focused groups, in a highly collaborative setting. The position involves regular interaction with external contract manufacturers and key suppliers to support scale production and ensure design transfer. The environment supports focused design work, hands-on proto@type evaluation, and frequent technical discussions aimed at advancing innovative needle-free drug delivery technologies.
Job Type & Location
This is a Contract to Hire position based out of Golden, CO.
Pay and Benefits
The pay range for this position is $43.00 - $62.50/hr.
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 - 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)
Workplace Type
This is a fully onsite position in Golden,CO.
Application Deadline
This position is anticipated to close on May 25, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
