Senior Mechanical Engineer
The Senior Mechanical Engineer will be responsible for the end-to-end development and design of medical devices. This role requires a deep understanding of mechanical engineering principles, medical device regulations, and project management. The ideal candidate will have a proven track record of successfully bringing medical devices to market and a passion for improving healthcare through innovative engineering solutions.
Key Responsibilities:
- Lead the design and development of medical devices from initial concept through to production.
- Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and manufacturing.
- Conduct feasibility studies and risk assessments to ensure product safety and efficacy.
- Develop detailed engineering drawings, specifications, and documentation.
- Perform simulations and analyses to validate design concepts.
- Oversee prototyping, testing, and validation of medical devices.
- Ensure compliance with relevant medical device regulations and standards (e.g., ISO 13485, FDA).
- Manage project timelines, budgets, and resources effectively.
- Mentor and guide junior engineers and team members.
- Stay current with industry trends, technologies, and best practices.
Qualifications:
- Bachelor's or Master's degree in Mechanical Engineering or a related field.
- Minimum of 7 years of experience in mechanical engineering, with at least 5 years in medical device development.
- Strong knowledge of medical device regulations and standards.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
- Experience with finite element analysis (FEA) and computational fluid dynamics (CFD).
- Excellent problem-solving skills and attention to detail.
- Strong project management and leadership abilities.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
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