
Senior Mechanical Designer
2 days ago
We are seeking a highly skilled Mechanical Design Engineer to join our Product Development team for medical device development.
The ideal candidate will have hands-on experience in mechanical design, with strong proficiency in 3D modeling using SolidWorks along with Ansys or Hypermesh.
Main Responsibilities- Lead mechanical design efforts for electromechanical medical devices throughout the product lifecycle.
- Design and develop mechanical components, assemblies, and systems for new medical devices.
- Create detailed 3D models, drawings using SolidWorks along with Ansys or Hypermesh, and create product specifications adhering to medical device industry standards.
- Perform design calculations and simulations to ensure product reliability, safety, and functionality.
- Work closely with the NPD team, including electrical engineers, regulatory teams, and quality assurance, to ensure cohesive product development.
- Collaborate with manufacturing teams to support design for manufacturability (DFM) and assembly (DFA) principles.
- Lead or support prototype development and testing, including hands-on assembly and troubleshooting of mechanical prototypes.
- Interpret test results and iterate designs based on feedback and testing data.
- Ensure all designs meet regulatory and quality standards required for medical devices (e.g., ISO 13485, FDA guidelines).
- Document design changes and maintain comprehensive design history files.
- Identify areas for design improvement, cost reduction, and process optimization.
- Stay current with new technologies, design techniques, and medical device trends.
- Bachelor's degree in Mechanical Engineering or a related field.
- 3-5 years of hands-on experience in mechanical design, preferably in the medical device or similar highly regulated industries.
- Proficiency in 3D CAD modeling, 2D detail drawings specifically SolidWorks.
- Hands-on experience in Sheet metal, Machine design, and Manufacturing feasibility analysis.
- Familiarity with design and manufacturing processes, including prototyping, Design verification testing, and validation.
- Strong understanding of mechanical design principles, materials, and manufacturing processes.
- Good knowledge of product development life cycle, especially in the context of medical devices.
- Sound knowledge of GD&T, Experience in BOM (Bill of Material) structures.
- Ability to work independently and in a team environment.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills, both written and verbal.
- Experience in leading and designing for medical devices or healthcare products.
- Familiarity with regulatory requirements for medical device development (FDA, ISO 13485, etc.).
- Experience with design documentation and change control design control in a regulated environment.
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