This is a rare opportunity to take the lead technical role in the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. As part of a start-up organization working to develop a key unmet clinical need, you will be a key member of the team and help drive the development of the technology.
Reports directly to the Head of R&D
Key Responsibilities and Duties
- Lead design and development at a system level, generation of detailed specifications, including review and approval of sub-systems.
- Design systems, including robust design selection, material selection and assembly method selection. Detailing finished device specifications to ensure a robust and right first time device.
- Manage the sourcing, building and testing of systems; ensuring detailed and comprehensive data analysis to drive the device design in the optimal direction
- Define and manage the execution of comprehensive test suites to fully understand device design, risk and verify & validate it in line with device specifications.
- Proactive management of risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk based design.
- Ensure the device development follows good Design Control practices, in line with ISO13485. Generating a complete, audit ready, Design History File.
- Ensure Quality in the product's design for durability, usability, reliability, functionality, marketability and manufacturability
- Lead technical discussions with multiple internal and external stakeholders, adapting style and supporting material to suit the discussion to ensure clear understanding of all parties.
- Proactively ensure Company Goals are achieved and act an example to others in embodying the Company Values
- Technical: Technical Thought Leader with a detailed understanding of engineering principles across numerous design areas and extensive understanding of their subject matter. Has in-depth understanding and knowledge of materials and processes used in the design of different devices across the medical device and related industries, but especially as related to cardiovascular devices. You have strong technical skills in some or all of the following areas: cardiovascular anatomy and physiology, concept development, component and system design, material selection and sterilization method selection for medical devices, pre-clinical assessments, test method development, CAD, computational modelling.
- Experience with implantable cardiovascular devices and / or steerable catheter systems would be a distinct advantage
- Problem Solving: Drives a culture of data-driven problem solving that ensures the development of high quality devices. This includes implementing systems / processes for robust data capture, analysis and presentation of technical information to guide the decision-making process. Proposes and guides the use to tools and techniques for problem solving and analysis. Identifies and addresses areas of improvement.
- Innovation/ IP: Leads innovation across the company, ensuring maximum value in the IP portfolio.
- Project Management: Strong project management skills to lead cross-functional and external projects. Creative approaches to reducing project risks and shortening timelines while delivering business objectives. Effectively assigns and delegates activities to more junior engineers to maximise output. Uses experience to plan and manage budget requirements at a system or program level.
- Initiative: Takes initiative in driving the design to meet the key clinical and business needs. Sets an example in positively influencing the group to achieve business objectives, and to solve emergent problems before they escalate.
- People Skills: Builds relationships and resolves issues before they become problematic. Uses technical expertise to influence personnel in the company. Developed people skills to adjust style to work effectively with all levels within the organisation. Manages or coaches junior team members with respect to technical designs, developments and decision-making and sets a positive example for the team. Considers needs, skills, goals of more junior team members and adapts style to different staff members to most effectively encourage them.
- Communication: Effectively communicates throughout the organization and represents the organization as a Technical Thought Leader with external contacts including physicians and key suppliers. Leads discussions on key technical matters. Confidently represents the company both internally and externally. Ability to positively influence others to understand and respond to their perspective.
Education and Experience
- B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines
- 10 years of related experience in medical device mechanical design/product development
- Cardiovascular medical product development experience preferred
- Comprehensive ability to assess in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
- Detailed working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
- Experience interfacing with clinicians and reducing feedback to appropriate designs
- Excellent organizational and time management skills
Availability to travel is required
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