This position requires a qualified, highly motivated individual with very strong communication and organisational skills, and the required engineering competencies to support NPI projects as part of AuriGen’s’ product development team. Reporting to the Senior NPI Engineer, the NPI Engineer 1 will work with the R&D & Operations teams to generate creative solutions to support the transfer of AuriGen’s product design into a manufacturing environment.
Role and responsibilities:
· Provide technical and project input to NPI activities
· Lead and support management of AuriGen’s development partners, vendors and suppliers to execute the transfer of product design to Manufacturing to meet project deadlines
· 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.
· Honours degree in mechanical engineering, biomedical engineering, or related disciplines
· Minimum of two (2) years of related experience as an NPI engineer in medical device mechanical design/product development
· Strong process design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/structural heart/nitinol/delivery system medical products highly preferred
· Experienced in problem solving techniques and methodologies with broad biomedical materials and processing knowledge
· Class III medical product development experience involving clinical trials highly preferred
· Working knowledge of FDA, GMP, QSR and ISO 13485 requirements, and a good knowledge of design life cycles requirements.
· Proven ability in application of project management tools – schedule development, budget management, resource planning
· Strong people management & leadership skills
· Excellent organizational and time management skills
· Is creative, continually learning and exploring new ideas.
· A self-starter applies his/her own initiative in most situations.
· A good team player who works well in a small team environment.
· A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
· Capacity to make sound judgements while learning from mistakes.
· Attention to detail while maintaining awareness of longer-term objectives.
· Strong interpersonal skills, a demonstrated ability to influence his/her peers.
· Displays the highest levels of integrity
· Capacity to maintain the highest levels of confidentiality internally and externally
· Availability to travel is required.