Head of R & D Mechanical Engineering - Product Development

We are seeking for a highly skilled and experienced Mechanical Engineering R&D professional to lead the dynamic product development team of a fast-growing company with offices in US, UK and Spain. 
The company is specialised on cutting-edge high-precision medical devices, which aim to revolutionize its area of specialization. Its close-knit team cultivates an environment of creativity, innovation, rapid iteration and collaboration with both scientific, engineering and operations teams. The environment is dynamic, fast-paced and requires a self-starter attitude.

The ideal candidate will possess a strong background in mechanical engineering, with extensive experience in designing medical devices under ISO 13485 standards. Additionally, they will demonstrate exceptional leadership and management skills, driving the product design process from conception to production while prioritizing user experience and innovation.
A strong candidate will have experience bringing physical products to market in highly regulated areas. Ideally medical devices, but other areas such as aerospace and energy could also be relevant. You will be able to point to leading a team through the development phase of the product, including setting roadmaps, and managing a team to execute on time and on budget.
 
Responsibilities

• Lead and mentor a team of product designers and engineers, fostering a culture of creativity, collaboration, and excellence.
• Oversee the design and development of mechanical components and assemblies for medical devices, ensuring compliance with ISO 13485 standards.
• Drive feasibility studies, research and development, and testing of new and existing designs, utilizing a user-centered approach.
• Collaborate closely with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs to deliver successful projects on time and within budget.
• Facilitate design transfer to manufacturing and provide technical guidance and support during production.
• Develop and maintain comprehensive product design documentation, including design history files, risk management files, and technical specifications.
• Lead design reviews, verification and validation testing, and root cause analysis of design-related issues, ensuring continuous improvement.
• Drive innovation by exploring new technologies and methodologies to enhance product design and performance.
• User experience and product design oriented emphasizing aesthetics, ergonomics, and usability.

Requirements

• Bachelor's degree in Mechanical Engineering or related field; Master's degree preferred.
• 10+ years of experience in mechanical engineering, ideally with a focus on medical device design under ISO 13485 standards.
• Proven leadership experience, with a track record of successfully managing and motivating cross-functional teams.
• Expertise in CAD software such as SolidWorks, Pro/Engineer, OnShape, or similar, with a strong emphasis on design for manufacturability.
• Extensive experience creating part drawings using Geometric Dimensioning & Tolerancing.
• In-depth knowledge of mechanical systems design, including prototyping, testing, debugging, and analysis.
• Extensive experience with manufacturing processes such as injection molding, sheet metal fabrication, CNC machining, and additive manufacturing.
• Excellent communication and collaboration skills, with the ability to effectively interact with diverse teams and stakeholders.
• Strong problem-solving abilities and a creative mindset to develop innovative solutions to complex challenges.
• Proficiency in written and spoken English is essential.

If you are a dynamic leader with a passion for driving innovation in medical device design and meet the above requirements, we ar looking forward to know you. We offer competitive compensation and benefits packages, along with the opportunity to make a meaningful impact in a fast-paced and exciting environment.