Senior Design Lead - MDR, 510(k), DHF Remediation

Job Summary

The Senior Design Lead is pivotal in shaping and overseeing the design direction for multiple projects within the Medical Device Regulations (MDR) landscape. This role emphasizes the importance of user-centric design while ensuring adherence to regulatory standards. The Senior Design Lead will drive innovation, set organizational design standards, and foster collaboration within design teams to achieve strategic business objectives.

Key Responsibilities

Bachelor's Degree in Mechanical Engineering with Min 8+ yrs of Exp in Medical Devices as Design Quality Engineer role As Design Quality Engineer, key focus on ensuring the safety, efficacy, and reliability of medical devices throughout their lifecycle, from design to post-market surveillance, adhering to relevant regulations and standards Strong understanding of medical device regulations, standards, and quality systems. Review of Surgical technique, Labels and IFU's Design Input and Output: Reviewing and validating design inputs, outputs like Review design intents, CTQ identification, Review application of Geometrical Design &Tolerance, Gauge/Inspection- Fixture design reviews, order and implementation, Input for Design For Manufacturability/Design For Inspection, Receiving inspection documents, and design control processes to ensure they meet requirements and standards. Risk Management: Participating in and leading risk management activities, including hazard analysis, FMEA (Failure Mode and Effects Analysis), and risk mitigation strategies. Verification and Validation: Ensuring that designs are verified and validated to meet intended use and performance requirements. Design Assurance: Working with product development teams to ensure that quality systems and design assurance processes are followed. Documentation: Managing and contr

Skill Requirements

1. Advanced Proficiency In Mdr Standards And Processes, With A Strong Understanding Of Regulatory Requirements Related To Medical Device Design.

2. Solid Experience In User-Centered Design Principles, Usability Testing, And Design Thinking Methodologies.

3. Excellent Skills In Design Tools And Technologies, Such As Sketch, Adobe Creative Suite, Or Figma.

4. Strong Understanding Of Iso 13485 And Its Impact On The Design Process In Medical Devices.

5. In-Depth Knowledge Of Emerging Technologies And Design Trends Relevant To The Healthcare Sector.

Other Requirements

1. Certification In Human Factors Engineering (Hfes) Or Design For Medical Devices Is Optional But Valuable.

2. Relevant Certifications In Iso Standards Or Medical Device Design Processes Are Highly Recommended.