Principal Product Development Engineer (Medical Devices)
Working within the R&D of Customer’s Team alongside other Engineers, the Principal Engineer will provide leadership throughout Medical Devices group and its business partners, and will maintain and provide technical support for the customer’s portfolio of released for sale products. The role will involve a broad range of activities for both internal and external customers and will include approving engineering changes, supporting Regulatory and Quality compliance projects, and Manufacturing and Supply Chain projects, and supporting Sales and Marketing through to the management of significant field safety actions. In addition to these duties there will be some need to work on new product development projects depending on business needs and resource availability.
Responsibilities listed below do not represent the full scope of duties and responsibilities, but aims to be representative of the fundamentals expected of a Principal Product Development Engineer.
All work will be carried out in accordance with company policies and procedures:
o Leverage understanding of first engineering principles, advanced engineering methods and design and process excellence methodologies in order to influence the course of product development activities.
o Actively assert departmental compliance with all quality policies, procedures and practices including Health Safety & Environment and Healthcare Compliance.
o Lead complex company-wide projects to deliver to business critical product development commitments.
o Conduct advanced research, investigation and problem solving.
o Remain abreast of, communicate and exploit technical trends of value to the organization.
o Superior understanding of medical standards (Knowledge of Orthopaedic domain would be an added advantage)
o Superior understanding and experience on the subject of of risk analysis procedures/methods/standards
o Ability to interact with cross functional teams in a multi dynamic cultural environment
o Exhibits superior leadership, time management, and decision making skills
o Works proactively, demonstrating a high level of initiative
o Communicates effectively and with confidence at all levels
o Utilizes strong interpersonal skills for team building and partnering
o Possesses a thorough understanding of the product development process for medical devices
o Exhibits a strong business acumen
o Demonstrates well developed project management skills
o Thrives under pressure and in situations of technical complexity.
o Utilizes superior coaching and mentoring skills
o Comfortable with using and facilitating a variety of problem solving methodologies
o Transposes own knowledge of manufacturing methods and limitations into cost effective design solutions.
o Support technical requests from all areas of the business in relation to any of the customer's released for sale product ranges such as manufacturing requests for change, supporting local market regulatory submissions and supporting technical enquiries from Sales Staff and Surgeons.
o Management of product risk management files, ensuring design verification and validation is performed such as tolerance analysis, FEA, lab testing where appropriate to demonstrate the on-going safety and efficacy of products.
o Support for product maintenance and quality system activities such as post market surveillance and customer complaint investigations.
o Responsible for participating on cross functional project teams through all phases of the product development process from gathering initial customer requirements through to full product launch.
o Will meet delivery promise in terms of budget and timescales.