This is a key role in the Company and will report directly to the CEO.
The Senior R&D Engineer will lead the design and development of a pipeline of products from conception to completion & commercialisation for the enteral feeding device market.
The Senior R&D Engineer will also lead the company’s management of it’s outsourced manufacturing partner for prototype and pilot production builds and will work seamlessly with cross-functional teams to ensure that company’s products get to market on time & to budget, meeting the required quality and regulatory standards for such enteral feeding devices.
This is a great opportunity for the successful candidate to join a start-up company in its early stages, and to get the opportunity to make a significant impact as they grow their skills and experiences.
- Lead the R&D team to design and develop a portfolio of novel enteral feeding delivery systems devices in line with user needs, including generating creative solutions to problems.
- Provide technical leadership & support to the R&D project teams.
- Required to manage and drive R&D and certain Operations project activities.
- Liaise with Physicians to understand and gather specific product requirements.
- Identify and manage key risks throughout the product development lifecycle.
- Contribute to innovation through filing of disclosures and patents.
- Responsible for developing device specifications, in line with user needs and design inputs. This will include the creation of detailed component and finished device assembly drawings/specifications.
- Responsible for developing and performing design verification and validation strategies, plans and execution activities to clearly defined acceptance criteria.
- Reviews engineering specifications and drawings, proposing design modifications to improve system design within cost and other performance requirements.
- Lead and support Design Reviews with a focus on Requirements definition and V&V activities.
- Lead and support risk management activities, including FMEAs, to ensure robust and reliable designs.
- Lead, develop and implement design characterization, DOEs and design verification strategies.
- Work with stakeholders to identify, define and document constraints and assumptions for the development and testing of medical devices.
- Identify and manage vendors in relation to components, processes, and equipment.
- Develop test methods and fixturing for product verification and validation; analyse test data and interpret to identify optimal solution.
- Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability.
- Develop and manage manufacturing activities, including managing the outsourced manufacturing relationship for prototype and pilot production builds on to production.
- Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation. This will include the completion of Design History Files, Design Inputs, Outputs, Design Reviews, Log books, etc as necessary. Ensure full traceability of Design Development and control of changes.
- Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are fully developed to allow product/process validation to begin.
- Provide comprehensive training to production, quality and technical staff to ensure a smooth production start including validations and records.
- Train and develop associate engineers and other technical staff. Assign tasks and provide support and assistance to the development team.
- Provide support to the Senior Management team of the Company as required.
- B.S. and/or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related disciplines.
- 8-10+ years of relevant experience in the medical device industry.
- Strong management, design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
- Highly effective and demonstrable Project Management skills.
- Team Player who can collaboratively work with cross-functional groups and proactively manage relationships, while also getting results.
- Effective People Management & communications experience.
- A diverse range of experience developing a range of Class II/III medical products for the U.S., European markets & ROW Markets.
- Highly motivated to make a difference by providing solutions to an underserved medical need worldwide.