Senior R&D Engineer

Summary:Applies knowledge of R&D engineering principles and methods to ensure compliance with regulatory requirements and systemsprocedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the key responsibilities for details. Job Responsibilities:Create, test, andor improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principlesGenerate work instructions, test methods, engineering models and drawingsprototypes, etc., to establishcharacterize product andor process specificationsCreateupdate more complex design control documents including requirement specs, and risk documents (Design requirements document DRD, design verifications plan, DFMEA, technical summaries, alignment of design documents with risk control documents such as Risk management worksheet or AFMEAPFMEA)Develop and execute engineering project plans ( design verification Plan)Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliersAssign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workEvaluate input and form a technical recommendation including designing parts, components and subsystemsTrain, coach, and guide lower level employees on routine proceduresOther duties assigned by Leadership. Skills:Proven expertise in usage of MS Office Suite; CAD experience preferred PTC Creo for CAD and Windchill for product life cycle management ( design controls elements such as Design requirement documents, drawings and risk control documents)Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesPrevious experience working with labindustrial equipment required (if applicable)Substantial understanding and knowledge of principles, theories, and concepts relevant to EngineeringStrong problem-solving, organizational, analytical and critical thinking skillsSubstantial understanding of processes and equipment used in assigned workGood leadership skills and ability to influence changeKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturingStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influencecontrol EducationExperience:Bachelor's Degree in Engineering or Scientific field, 4 years years experience Required orMaster's Degree or equivalent in Engineering or Scientific field, 3 years years experience Required orPh.D. or equivalent in Engineering or Scientific field Required

Created: 2025-02-22