Job Overview
We are seeking a dynamic and innovative Medical Device Engineer to join our cutting-edge biomedical engineering team. In this role, you will drive the development, design, and validation of advanced medical devices that improve patient outcomes worldwide. You will collaborate across multidisciplinary teams to translate clinical needs into reliable, compliant, and innovative products. Your expertise in engineering principles, regulatory standards, and research methodologies will be pivotal in bringing life-changing medical solutions from concept to production.
Duties
- Lead the design and development of medical devices using CAD software such as SolidWorks and other 3D modeling tools, ensuring mechanical robustness and compliance with industry standards.
- Conduct detailed mechanical design analyses, including GD&T (Geometric Dimensioning and Tolerancing), to ensure precision manufacturing and assembly.
- Develop and execute design of experiments (DOE) to optimize device performance, reliability, and manufacturability through rigorous testing protocols.
- Manage projects, milestones, and documentation in accordance with regulatory requirements such as FDA regulations, ISO standards, and GMP (Good Manufacturing Practice).
- Perform laboratory experiments and testing to validate/verify device functionality and safety.
- Analyze data statistically to support research findings, validate design choices, and prepare technical reports for regulatory submissions.
- Ensure all engineering activities adhere to design controls, validation protocols, and regulatory/legal compliance standards for medical devices.
Skills
- Extensive knowledge of biomedical engineering principles specific to medical device design and development.
- Proficiency in CAD software such as SolidWorks or equivalent for 3D modeling and product design.
- Strong understanding of regulatory frameworks including FDA regulations, EUMDR, ISO standards (e.g., ISO ), GLP (Good Laboratory Practice), CGMP (Current Good Manufacturing Practice), ASTM standards and design controls.
- Experience in project management with the ability to coordinate multiple tasks simultaneously while maintaining quality standards.
- Skilled in statistical analysis for research data interpretation and experimental design for product validation.
- Familiarity with engineering validation processes for manufacturing environments and clinical trial support.
- Excellent communication skills for effective collaboration across multidisciplinary teams in a fast-paced innovation environment.
Join us to be part of a passionate team dedicated to advancing healthcare technology through innovative engineering solutions!
Pay: $81,000.00 - $115,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- On-the-job training
- Paid time off
- Vision insurance
Work Location: In person
