Mechanical Design Engineer

Job Title:

Mechanical Design Engineer Job Description We are seeking a Mechanical Design Engineer to support the development of next-generation, needle-free drug delivery systems. In this role, you will focus on hands-on mechanical design, prototyping, and design controls for a new pre-filled syringe application. You will take mechanical concepts from proof-of-concept through validation while working closely with quality, clinical, and manufacturing teams to ensure designs meet FDA and ISO requirements. This is a highly visible position supporting a growing product portfolio with significant global clinical and commercial impact, offering real ownership in high-impact new product development rather than incremental changes. Responsibilities Lead and contribute to mechanical design activities for needle-free drug delivery systems and pre-filled syringe applications from proof-of-concept through design verification and validation. Follow a structured, stage-gate new product development (NPD) process for medical devices, ensuring that all design phases are properly documented and executed. Create, refine, and release detailed 3D CAD models and final production drawings for disposable and syringe-based components using SolidWorks or equivalent 3D CAD software. Apply ISO and FDA design control principles to author, maintain, and update Design History Files (DHF) throughout the product lifecycle. Support internal and external audits and inspections by providing accurate documentation and demonstrating compliance with regulatory and quality standards. Implement Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to optimize designs for scalable manufacturing and robust assembly. Collaborate with contract manufacturers and key suppliers to ensure designs can be produced reliably and cost-effectively at scale. Plan and manage prototype builds, including coordinating with vendors to fabricate components and assemblies. Conduct hands-on prototyping, testing iterations, and design refinements based on test results and feedback from cross-functional partners. Engage directly with external vendors to oversee validation activities and ensure prototype and production parts meet design specifications. Work cross-functionally with engineering, quality, clinical, and customer-focused teams to align design decisions with clinical needs, user requirements, and regulatory expectations. Contribute to risk management activities such as DFMEA to identify, assess, and mitigate potential design risks where applicable. Support documentation and reporting for new product development, including test plans, test reports, and design review materials. Participate in design reviews and provide clear technical rationale for design choices, trade-offs, and risk mitigations. Build strong, collaborative relationships with internal and external stakeholders to drive timely progress across the development lifecycle. Essential Skills At least 1 year of experience in mechanical design engineering or a closely related role. Hands-on experience designing medical devices in a regulated environment. Proficiency in SolidWorks or equivalent 3D CAD software for creating 3D models and production drawings. Experience supporting new product development activities from early concept through testing or verification phases. Ability to work within ISO and FDA-regulated environments and follow formal design control processes. Strong mechanical design fundamentals, including tolerance analysis, material selection, and mechanism design for disposable or syringe-based components. Demonstrated experience with prototyping, including building, testing, and iterating on mechanical concepts. Bachelor's degree in Mechanical Engineering or a related engineering discipline. Strong communication skills to collaborate effectively with cross-functional teams including engineering, quality, clinical, and customer-focused groups. Ability to manage multiple tasks and priorities within a structured NPD and design control framework. Additional Skills & Qualifications Working knowledge of ISO and FDA design controls, including practical experience with Design History Files (DHF) and design documentation. Experience supporting medical device new product development from concept through testing and verification. Background in pre-filled syringes, disposable medical devices, or drug delivery systems. Direct exposure to FDA inspections or ISO audits in a medical device context. Experience with Design of Experiments (DOE) to plan and analyze structured test programs. Familiarity with DFMEA and other risk management tools for identifying and mitigating design risks. Experience working with or managing external vendors, including prototype suppliers and contract manufacturers. Prior involvement in light project leadership responsibilities, such as coordinating small workstreams or vendor activities. Motivation to build highly marketable medical device new product development credentials in a high-impact, regulated environment. Interest in working on life-saving, needle-free drug delivery technology used in global health programs. 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 vendors to support prototype builds and scale-up to production. The environment emphasizes structured design controls, documentation, and compliance, while also providing opportunities for hands-on design, testing, and iteration in support of globally impactful medical device products. Job Type & Location This is a Contract position based out of Golden, CO. Pay and Benefits The pay range for this position is $35.00 - $45.00/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 Apr 27, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.