Job Summary

The Senior Design Lead plays a pivotal role in overseeing multiple design teams to establish and uphold organizational design standards. This position is crucial in driving innovation within the design process, ensuring that design efforts significantly contribute to achieving business objectives. The Senior Design Lead will influence the overall design vision and strategy, ensuring that products not only meet user expectations but also enhance user experiences.

Key Responsibilities

Design responsibilities

• Product design and development: Design mechanical components, assemblies, and systems for medical devices from concept to production using Creo & SolidWorks. This can include both purely mechanical devices and electromechanical systems.

Hands on experience in PDM / PLM (SAP-ECTR) for managing lifecycle of the components, managing ECO / ECR (SAP).

• Prototyping and testing: Build and test prototypes to validate design performance against specifications and ensure safety and reliability.
• Material selection: Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness.
• Risk management: Participate in risk assessment activities, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential design risks.
• Design for manufacturing and assembly (DFM/DFA): Designs are optimized to ensure they can be efficiently produced and assembled, considering manufacturing processes.

Drafting responsibilities

• Creating technical drawings: Using advanced CAD software such as Creo or SolidWorks, create detailed 2D drawings of components and assemblies.
• Applying GD&T: Apply Geometric Dimensioning and Tolerancing (GD&T) to communicate design tolerances and specifications precisely for accurate manufacturing.
• Bill of Materials (BOM) management: Generate and maintain the BOM, which is a comprehensive list of all raw materials, components, and assemblies needed to manufacture the final product.
• Document control: Organize and maintain a comprehensive Design History File (DHF), which documents the entire design process, including inputs, outputs, verification, and validation records.
• Revision control: Revising and updating technical drawings and documentation as needed and for managing the engineering change order (ECO) process.

Regulatory and cross-functional responsibilities

• Regulatory compliance: Ensuring all design and documentation adheres to strict medical device regulations from bodies like the FDA and standards like ISO 13485.
• Cross-functional collaboration: Work with a range of professionals, including quality assurance, regulatory affairs, manufacturing, and sourcing, to bring a product from concept to launch.
• Vendor management: Assist in identifying and qualifying vendors for components and manufacturing processes, and communicate with suppliers to address design feasibility

Skill Requirements

1. Advanced Proficiency In Product Design Tools And Methodologies.
2. Strong Understanding Of Design For Manufacture And Assembly (Dfma) Principles.
3. In-Depth Knowledge Of Geometric Dimensioning And Tolerancing (Gd&T) Standards.
4. Excellent Communication And Leadership Skills To Guide Design Teams Effectively.
5. Ability To Analyze And Synthesize Information To Drive Design Innovation.

Other Requirements

1. Optional But Valuable Certifications Include Certified Product Designer (Cpd) Or Professional Design Certification (Pdc).