Job Description:
Position Summary
We are seeking a hands-on, technically accomplished, Mechanical Engineer.
This individual will Create mechanical design of complex infusion hardware with core focus on including their loading, actuation, safety systems, and performance under all clinical conditions.
Key Responsibilities
Technical
• Create the mechanical design of complex infusion hardware with core focus on:
• Pumping mechanism design and optimization
• Fluid path layout and actuation systems
• Loading interfaces that ensure intuitive, error-proof use
• Safety-critical features such as anti-flowback, occlusion protection, and alarm actuation
• Ensure robust performance under variable real-world conditions, including variations in viscosity, backpressure, orientation, mobility, and power availability.
• Guide integration of sensing and feedback systems (e.g., pressure, flow, torque) into mechanical assemblies to support closed-loop control, dosage accuracy, and error detection.
• Apply advanced engineering tools and practices, including FEA, FMEA, and risk-based design to deliver high-reliability, manufacturable solutions.
• Ensure all designs comply with regulatory and quality standards, including FDA, ISO 13485, and IEC 60601.
Qualifications
• Bachelor’s or Master’s degree in Mechanical Engineering or closely related field.
• 5+ years of mechanical design experience in complex hardware development, preferably in medical devices or regulated industries.
• Strong knowledge of medical-grade materials, fluid interfaces, sensor integration, and design for high-volume manufacturing.
• Exposure to Agile hardware development, Six Sigma (Green/Black Belt), and lean engineering preferred.
• Proven track record of technical ownership and product delivery in fast-paced development environments.
ABOUT Ztek:
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek’s diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.
Disclaimer:
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at "To apply, click the Monster apply button" Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.