Position Overview:
As a Mechanical Design Engineer with expertise in medical devices, you will be responsible for the design, development, and implementation of mechanical systems and components for medical devices. You will collaborate with cross-functional teams, including electrical engineers, software engineers, and manufacturing engineers, to ensure the successful delivery of safe, reliable, and high-quality medical devices. Your role will involve designing mechanical components, conducting analysis and simulation, creating technical drawings, and ensuring compliance with regulatory standards.
Key Responsibilities:
Mechanical Design and Development for Medical Devices:
- Design mechanical components, systems, and assemblies for medical devices, considering performance, reliability, safety, and regulatory requirements.
- Collaborate with cross-functional teams to define mechanical requirements and specifications basedon product functionality and regulatory standards.
- Utilize CAD software (e.g., SolidWorks, UG NX, Creo) to create 3D models and technical drawings of mechanical designs.
- Conduct analysis and simulation (e.g., finite element analysis, tolerance analysis) to optimize mechanical designs and ensure proper functioning.
Material Selection and Compatibility:
- Select appropriate materials for mechanical components, considering biocompatibility, durability, sterilization compatibility, and manufacturing processes.
- Evaluate material compatibility with various medical device applications and ensure compliance with regulatory standards.
- Collaborate with material engineers and suppliers to assess material properties, availability, and cost-effectiveness.
Design for Manufacturability and Assembly:
- Optimize mechanical designs for manufacturability, considering manufacturing processes, cost, and scalability.
- Collaborate with manufacturing engineers to ensure seamless transfer of designs to production, addressing design-related manufacturing challenges.
- Design mechanical components and assemblies that are easy to assemble, test, and maintain.
Testing and Verification:
- Develop and execute test plans to verify and validate mechanical designs, including functional testing, performance testing, and reliability testing.
- Collaborate with quality engineers and regulatory specialists to ensure compliance with relevant regulatory standards and guidelines.
- Perform mechanical testing and analysis, such as stress analysis, vibration testing, and environmental testing, to assess mechanical performance and durability.
Compliance with Regulatory Standards:
- Ensure compliance with relevant regulatory standards and guidelines for medical devices, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and applicable international standards (e.g., IEC 60601).
- Stay updated with evolving regulations and standards related to mechanical design in medical devices.
- Collaborate with quality engineers and regulatory specialists to prepare technical documentation and support regulatory submissions.
Technical Leadership and Collaboration:
- Provide technical guidance and expertise to cross-functional teams regarding mechanical design, materials, and manufacturing processes for medical devices.
- Collaborate with electrical engineers, software engineers, and manufacturing engineers to align on project requirements, timelines, and deliverables.
- Participate in design reviews and risk assessments to ensure mechanical-related risks are identified and mitigated.
- Mentor and support junior engineers, reviewing their work, and offering technical guidance.
Documentation and Reporting:
- Create and maintain accurate and comprehensive documentation of mechanical designs, specifications, test procedures, and verification reports for medical devices.
- Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
- Contribute to the development and maintenance of mechanical design standards, guidelines, and best practices.
Qualifications and Skills:
- Bachelor’s or master’s degree in mechanical engineering or a related field.
- Proven experience (typically 7-10 years) in mechanical design and development, with a focus on medical devices.
- Proficiency in CAD software (e.g., SolidWorks, UG NX, Creo) for 3D modelling and technical drawings.
- Strong understanding of sheet metals and plastic component designs.
- Should have experience in Electromechanical systems, sub-systems design and development.
- Strong GD & T and tolerance stack up analysis.