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New Product Introduction Engineer
- Full Time
- On site
- Mid-Senior Level
Our Client, an innovative Medical Device Company based in Galway City, is hiring an NPI Engineer. Reporting to the NPI Senior Engineer, the successful candidate will work as part of the Product Development team to generate creative solutions to problems and ensure the delivery of product development solutions in line with target goals. This is an exciting opportunity to join an established engineering team and develop technology that will change the lives of millions.
Job Responsibilities include but are not limited to the following:
- Provide technical and project input to NPI activities.
- Develop a deep understanding of the disease state, support delivery of user needs in a product solution.
- Contribute to New Product Introduction to include development of product design, product specifications, Manufacturing documentation (to include Bill of Material, Device Master Record, Risk Management requirements/Quality Inspections, Work Instructions) process validations identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with Procedures and Regulatory standards.
- Source and implement tooling, equipment and technologies, as required to implement the manufacture of new and existing production. Co-ordinate supply chain activities for raw materials
- Support New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design History Files in accordance with procedures and Regulatory Standards.
- Work with manufacturing to plan and implement manufacturing cell lay-outs, workstation design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.
- Lead generation and testing of prototypes; analyse test data and interpret to identify optimal solution(s).
- Identify and select product materials, assembly methods and define process settings. Lead sourcing, testing and approval of materials.
- Execute product evaluation and validation, including development of test methods to demonstrate device performance to meet technical specifications established through the design development process. Develop and execute test method validations.
- Generate technical documentation (procedures, protocols, specifications, reports) for the Product Design History File and Device Master Records & develop detailed component and finished device assembly drawings/specifications to support NPI.
- Support identification and management of key risks throughout the product lifecycle
- Support development & delivery of technical product development project plans to performance, time, and cost targets.
- Support the implementation of design to the manufacturing operation through well defined, robust processes.
- Leverage and liaise with external resources to achieve project goals
- Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability.
- Honour’s degree in mechanical engineering, biomedical engineering, or related disciplines
- Minimum of 2-3 years of related engineering experience in medical device new product introduction, manufacturing, or process engineering
- Experienced in problem solving techniques and methodologies with broad biomedical materials and processing knowledge.
- Working knowledge of FDA, GMP, QSR and ISO 13485 requirements, and a good knowledge of design life cycle requirements.
- Excellent organizational and time management skills
- Prior experience in cardiovascular/structural heart/nitinol/delivery system medical products is desirable.
- Must be a self-starter, motivated and passionate about developing new products in a small fast-paced team environment.
- Must have strong written, oral, and interpersonal communication skills.
- Ability to travel occasionally if required.
This is a fantastic opportunity for the right candidate and offers Partial remote working, Flexitime, DIS and income protection*
*post probationary period
Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.
Pale Blue Dot® Recruitment
“The Resource for the MedTech Workforce”