Senior R&D Engineer
CroiValve is looking to hire a Senior R&D Engineer who will support the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval.
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 designing with nitinol for structural heart or closely related devices is preferred, but not essential. Tissue engineering experience would be highly preferred, but also not essential.
This role is site based in our Dublin office. Occasional work from home is facilitated but the role is predominantly on site.
Reporting Lines
Reports directly to the Head of R&D
Key Responsibilities and Duties
Responsible for developing device specifications, in line with user needs and Design Inputs, including innovative solutions. Provide technical and project leadership for R&D activities
Design sub-assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications
Build and test prototypes; analyse test data and interpret to identify optimal solution
Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.
Develop test methods for product evaluation and validation. Develop and execute test method validations.
Leverage and liaise with external resources to achieve project goals
Drives risk management for sub-assemblies under their responsibility and drives a system level risk based design approach.
Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
Ensure interactions with colleagues/stakeholders fully reflects the company values:
o One Team: working together to ensure the whole is greater than the sum of the parts
o Personal Ownership: deliver on commitments
o Open Communication: Honest open-minded communication
o Fun: celebrate the successes
o Continuous Learning: at an individual and company level
o Solution Orientated: Identify problems but focus your energy on solutions
o Quality Focused: patient safety comes first
Essential Requirements
Technical: Strong technical capability with detailed understanding of technical principles, materials and processes used in the manufacture of medical devices and sub-system. Applies extensive technical expertise to product development for areas under their responsibility. Provides solutions to difficult technical issues associated with specific projects.
Problem Solving: Supports a culture of data-driven problem solving that ensure development of high quality devices. Promotes best practice in relation to capturing, analysis and communicating data to feed into technical decision-making across the company.
Innovation/ IP: Actively supports team innovation through regular contribution of disclosures to companies patent portfolio.
Project Management: Effective project management skills, including planning, scenario and contingency mapping. Management of activities at a sub-system level, including delegation of discrete work package to more junior engineers. Ensures timelines are met. Effective in identifying and communicating project risks and requirements to mitigate these risks. Contributes through self and others to ensure completion of projects. Effectively generates budget needs for development at sub-system / system level buy mapping-out the activities and resource requirements.
Initiative: Takes initiative to drive continuous improvement and reach business objectives. Leads discussions to drive team decisions as required.
People Skills: Strong ability to build relationships and resolve people issues that arise. Positively influences team and cross-functional interactions. Mentors junior team members and sets a positive example for the team, encouraging growth of more junior engineering staff.
Communication: Demonstrated ability to communicate effectively with internal and external stakeholders. Strong presentation of technical information to guide the decision-making process.
Education and Experience
B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
Five years of related experience in medical device mechanical design/product development
Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
Experience interfacing with clinicians and reducing feedback to device concept
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.
To apply for this position please send your CV and cover letter to info@croivalve.com