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Mechanical Engineering Lead
3 weeks ago
About Us:
We are a global biopharmaceuticals company that combines cutting-edge biosimilars and innovative healthcare products to bring hope to millions of patients worldwide.
Our mission is to make a positive impact on people's lives by fostering a culture of innovation, patient-centricity, and sustainability.
As a multicultural organization, we value diversity and inclusion, creating an environment where employees can thrive and grow with us.
We have a long-term commitment to delivering high-quality, affordable biosimilars to patients globally.
Job Summary:
The Electro-Mechanical Device Development Manager will lead the design, qualification, and development of new and existing electro-mechanical medical devices.
Key Responsibilities:
- Develop and manage multiple projects from new product development to life cycle management and sustaining engineering.
- Create design requirements and development specifications based on customer or user needs.
- Contribute to the development and documentation of electro-mechanical system architectures.
- Participate in ideations, troubleshooting, and problem-solving efforts related to new product development and sustaining projects.
- Ensure hands-on experience in Design History File compilation and technical file documentation.
- Familiarity with regulatory standards such as 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, and IEC/EN 62366 Application of Usability Engineering to Medical Devices.
- Experience in complaint investigation, corrective action, and preventive action systems, statistical methods, quality risk management, and post-market surveillance.
- Create and develop designs of electro-mechanical assemblies, mechanisms, and component parts for medical devices meeting set requirements.
- Perform in-depth mechanical analysis and calculations including kinematic analysis, tolerance analysis, structural analysis- FEA to evaluate design robustness and ensure consistent performance and safety of critical functions.
- Ensure successful integration of electro-mechanical design elements with other components.
- Build and test design concepts and engineering prototypes for verification, compiling and presenting data to support design verification of new products in accordance with company and regulatory requirements.
- Lead activities related to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures to ensure that resulting devices can be adequately manufactured and verified.
- Must participate in design reviews for reviewing design changes and seeking management approval to move forward.
Requirements:
- A graduate or postgraduate degree in Mechanical or related engineering with a minimum of 8 years of related experience. Experience in medical device lifecycle management is preferred.
- Hands-on experience in electromechanical product development, preferably medical devices.
- Knowledge and experience using CAD systems for mechanical design and analysis (SOLIDWORKS preferred).
- Familiarity with industry standards such as IEC 60601, ANSI, and ASTM is preferred.
- Knowledge of risk assessment, root cause analysis procedures, DFMEA, PFMEA, ISO, etc., is desirable.
- Knowledge of DFM & DFA with respect to ease of manufacture and assembly.
- Knowledge of design and manufacturing engineering of metal and plastic parts is required.
- Excellent communication skills, written and oral, including technical documentation and presentation skills.