Lead Engineer, Mechanical
ExternalFull-timeOn-site4d ago
CADComplianceDocumentationSolidWorks
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Responsibilities
- Lead and manage the mechanical design and development of complex medical devices, sub-assemblies, and components, ensuring compliance with medical device regulations and industry standards.
- Conduct advanced engineering analysis (e.g., FEA, CFD) to optimize designs for performance, reliability, manufacturability, and cost-effectiveness.
- Collaborate cross-functionally with electrical, software, systems, and manufacturing teams to ensure seamless integration and successful product launch.
- Develop and execute verification and validation test plans for mechanical systems, analyzing results and implementing corrective actions.
- Execute design reviews, risk assessments, and FMEA processes throughout the product development lifecycle.
- Identify and evaluate new technologies, materials, and manufacturing processes to enhance product performance and reduce costs.
- Maintain accurate and detailed design documentation, including CAD models, drawings, specifications, and technical reports.
- Qualifications**
- Bachelor's degree in Mechanical Engineering or a related discipline. Master's degree is preferred.
- Minimum of 5 years of experience in mechanical design and development, preferably within the medical device industry.
- Proven expertise in CAD software (e.g., SolidWorks, Creo, NX) and advanced simulation tools (e.g., Ansys, Abaqus).
- Understanding of medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and design control processes.
- Extensive experience with various manufacturing processes (e.g., injection molding, machining, sheet metal fabrication, additive manufacturing).
- Strong communication and interpersonal skills, capable of effectively collaborating with diverse cross-functional teams and external partners.
- Fluency in English (written and spoken) is required.
- Inclusion and Diversity
- We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
Benefits
Health insurance
Additional Information
Job Description Summary GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. tex Job Description
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