The Process Development Engineer provides leadership, support and guidance to the project teams tasked with the development and transfers of new medical device products in compliance with applicable EU and FDA regulations. The Process Development Engineer will take responsibility for several projects through the design & transfer cycle and will interface with R&D, clinical, quality, regulatory and operations teams.
· Provides technical leadership and support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle.
· Defines capacity and resource requirements, including recruitment, mentoring and development of the team to meet established project milestones.
· Co-ordination of New Product Introduction (NPI) in the manufacturing plant including face-to-face meetings, teleconferences and regular updates on project activities, milestones, and status.
· Development, execution and management of process validation activities.
· Manages a small team of Engineers and Technicians within the Group.
· Mentor / Support Engineers through the design / transfer cycle requirements.
· Liaises with Business Development, Manufacturing & Quality to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
· Supports & Facilitates customer correspondence for several key projects.
· Develops and implements programs in conjunction with Manufacturing Engineering, Operations and Quality Functions which drive a continuous improvement approach in the design for manufacture effectiveness.
· Provide technical input & ownership throughout the PRP process at various stages.
· Manages development projects in compliance with approved procedures and in adherence to ISO and FDA regulations.
· Completing product, process and material changes through Process characterization, validation (IQ, OQ, PQ), change control and documentation updates.
· Support the writing and release of validation documentation including FMEA's, Validation Plans, protocols and reports.
· Degree Qualified in Engineering or Science related discipline
· Minimum 5 years Engineering experience in Medical Device industry or other regulated industry
Competencies and Attributes
· Demonstrable Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820). Knowledge of Stage-Gate process and/or Product Development life cycle.
· Competency using SolidWorks to produce ISO compliant drawing specifications.
· Ability to manage a high performing team to achieve desired outcomes.
· Is creative, continually stimulates his/her team to learn and explore new ideas.
· A strong team player who builds and cultivates a winning culture though the team.
· A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation. Is comfortable and confident in presenting to customers or other external bodies.
· Capacity to make sound judgements relating to the effective management of the company’s resources.
· Has a strong understanding and application of project management tools.
· 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 and diplomacy.
· Capacity to maintain the highest levels of confidentiality internally and externally.
· Acts in conjunction with his/her management peers as a champion of company values and standards.
· Sets prioritizes for projects and activities and reviews with other managers and team to ensure alignment. Can translate business strategy into clear priorities.
· Leads team planning & update sessions, demonstrates personal accountability & leadership to help the function/ company achieve its goals. Inspires team members to achieve expected progress against priorities & goals.