Medical Devices Mechanical Engineer - Rockville, United States - latitude
Description
Due to federal government regulations to obtain a security clearance US Citizenship is requiredPosition Overview:
As a Mechanical Engineer specializing in medical devices, you will be responsible for designing, developing, and testing mechanical components and systems for our next-generation medical devices.
You will collaborate with cross-functional teams to translate product requirements into innovative design solutions, ensuring compliance with regulatory standards and industry best practices.
The ideal candidate will have a strong background in mechanical engineering, experience in medical device design, and a passion for driving innovation in healthcare technology.
Key Responsibilities:
Product Design and Development:
Lead the mechanical design and development of medical devices, including concept generation, detailed design, prototyping, and validation testing.
Utilize CAD software (e.g., SolidWorks) to create 3D models, assemblies, and detailed drawings of mechanical components and systems.
Design Verification and Validation:
Conduct verification and validation testing to ensure that mechanical designs meet performance requirements, regulatory standards, and user needs.
Analyze test results, identify areas for improvement, and implement design modifications as necessary to optimize product performance and reliability.
Regulatory Compliance:
Ensure compliance with regulatory requirements and industry standards for medical device design, including FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO Prepare and maintain documentation (e.g., design history files, technical specifications) to support regulatory submissions and audits.
Cross-Functional Collaboration:
Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive the successful development and commercialization of medical devices.
Continuous Improvement:
Identify opportunities for process improvement and innovation in mechanical design methodologies, tools, and techniques.
Stay abreast of industry trends, emerging technologies, and best practices in medical device design and engineering.
Qualifications:
Bachelor's degree in Mechanical Engineering or related field; advanced degree (e.g., Master's, PhD) preferred.1+ years of experience in mechanical engineering, with a focus on medical device design and development.
Strong understanding of mechanical engineering principles, materials selection, and manufacturing processes relevant to medical devices.
Experience with design control processes, risk management, and regulatory requirements for medical devices (e.g., FDA, ISO).Excellent communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and external partners.
$70,000 - $100,000 a year