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Medical Devices Design Manager

2 months ago

WottonunderEdge, United Kingdom Renishaw PLC Full time
Job Description

**Job Title:** Medical Devices Manager

**Company:** Renishaw PLC

**Location:** Remote (Hybrid working)

**Industry:** Medical Devices

Job Summary

We are seeking a highly skilled and experienced Medical Device Design Manager with a specialization in Robotics Design to join our innovative team. The successful candidate will lead and oversee the design and development of cutting-edge medical robotic devices, ensuring they meet the highest standards of quality, safety, and efficacy.

Key Responsibilities
  • **Leadership and Team Management:** Lead a multidisciplinary design team, fostering a collaborative and innovative work environment. Mentor and develop team members, providing guidance and support to enhance their technical and professional growth.
  • **Design and Development:** Design and develop medical robotic devices, ensuring compliance with industry standards and regulatory requirements. Utilize advanced design tools and methodologies to create innovative and user-friendly solutions.
  • **Project Management:** Oversee the product development lifecycle, from concept to commercialization. Collaborate with the project management office to develop project timelines, budgets, and resources to ensure timely and successful project completion.
  • **Regulatory Compliance:** Ensure all designs adhere to relevant regulatory standards, including FDA, ISO, and CE requirements. Prepare and maintain comprehensive documentation to support regulatory submissions and audits.
  • **Quality Assurance:** Implement robust quality assurance processes to ensure the safety, reliability, and performance of medical robotic devices. Collaborate with quality assurance teams to conduct rigorous testing and validation.
  • **Stakeholder Collaboration:** Work closely with cross-functional teams, including engineering, marketing, and clinical affairs, to align product design with market needs and user requirements. Engage with external partners, suppliers, and stakeholders to drive project success.
  • **Continuous Improvement:** Stay abreast of the latest advancements in robotics and medical device design. Identify opportunities for innovation and process improvement, integrating best practices and emerging technologies into the design process.
Qualifications
  • **Education:** Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Robotics, or a related field.
  • **Experience:** Circa 8 years of experience in medical device design, with a focus on robotics. Proven track record of successfully leading design projects from concept to market launch.
  • **Technical Expertise:** Strong knowledge of robotics design principles, mechanical systems, and control systems. Proficiency in CAD software and other design tools.
  • **Regulatory Knowledge:** In-depth understanding of medical device regulations and standards, including FDA, ISO 13485, IEC series, and CE marking.
  • **Leadership Skills:** Demonstrated ability to lead and inspire teams, manage projects, and drive results in a fast-paced environment.
  • **Analytical Skills:** Strong problem-solving skills and the ability to analyze complex technical challenges. Experience with risk management and failure mode analysis.
  • **Communication Skills:** Excellent verbal and written communication skills, with the ability to effectively communicate technical information to diverse audiences.
  • **Innovation and Creativity:** Passion for innovation and a creative mindset to develop groundbreaking solutions in medical device design.