Mechanical Engineer

Overview

Design and lead mechanical development of medical devices from concept to commercialization

Key Responsibilities

• cad modelling
• design transfer
• material selection
• subsystem integration
• verification testing
• risk management

Tasks

-Create 3D CAD models, detailed drawings, tolerance analyses, and design documentation in accordance with industry and FDA QSR requirements. -Support design transfer to manufacturing, including supplier qualification, process development, and sustaining engineering. -Select appropriate materials and manufacturing processes, such as injection molding, machining, extrusion, and 3D printing. -Collaborate with cross-functional teams to integrate mechanical, electrical, and software subsystems. -Develop and execute design verification and validation testing, including mechanical performance, biocompatibility, EN60601 safety, and reliability testing. -Work with and manage outside vendors. -Lead the mechanical design and development of medical devices, from concept through commercialization. -Drive risk management activities, including FMEA and fault-tree analysis, ensuring compliance with regulatory and quality standards.

Requirements

• solidworks
• mechanical engineering
• dfm/dfa
• medical device
• regulated
• problem solving

What You Bring

-Hands-on prototyping, testing, and lab experience. -Proficiency with SolidWorks CAD software. -Bachelor’s or Master’s degree in Mechanical Engineering or related field. -Demonstrated track record of taking products from concept through design transfer and commercialization. -Excellent problem-solving, communication, and project leadership skills. -Strong knowledge of DFM/DFA principles, prototyping methods, and manufacturing processes. -Experience working within regulated environments, such as FDA, IEC, and ISO. -7+ years of experience in mechanical design, with at least 3+ years in medical device development.

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Benefits

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

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms