University Bridge Fund

Companies

Jobs

Principal R&D Engineer

CroíValve

CroíValve

This job is no longer accepting applications

See open jobs at CroíValve.
Other Engineering
Dublin, Ireland
Posted on Monday, January 15, 2024

Principal R&D Engineer

CroíValve is developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR). We have an opening in our R&D team for a talented and motivated individual to join us to help lead our product development efforts through initial human studies towards commercialisation.

Candidates should be motivated to work in a startup environment at the leading edge of novel product development. Previous experience in a startup environment and previous experience of structural heart or closely related devices is preferred, but not essential.

This role is site based in our Dublin office. Occasional work from home is facilitated bit the role is predominantly on site.

The Role

Lead role in the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval.

Reporting Lines

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 IOS13485. 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

  • Ensure interactions with colleagues/stakeholders fully reflects the company values:

  1. One Team: working together to ensure the whole is greater than the sum of the parts

  2. Personal Ownership: deliver on commitments

  3. Open Communication: Honest open-minded communication

  4. Fun: celebrate the successes

  5. Continuous Learning: at an individual and company level

  6. Solution Orientated: Identify problems but focus your energy on solutions

  7. Quality Focused: patient safety comes first

Essential Requirements

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.

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 on 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 adopts 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. 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

  • Eight 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

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.

Linda Macken

This job is no longer accepting applications

See open jobs at CroíValve.