Senior Mechanical Engineer

About PENTAX MedicalOur mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.Position Opening: SENIOR MECHANICAL ENGINEERWhy JOIN Us?We are an established medical device leader that is preparing for high growth. This role will provide expertise in developing our essential engineering projects.PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy. SummaryThe Senior Mechanical Engineer will be a hands-on technical lead throughout the development process from concept through commercialization for mechanical devices. Develops innovative design concepts and ideas for new products, product improvements, manufacturing methods and test methods - create detailed designs as required. Oversees and conducts engineering concept and feasibility tasks, design, and development work on assigned projects including prototyping and testing and evaluation. Responsible for adhering to design controls and documenting all product development work in a Design History File. Lead small design or analysis teams, defining tasks and coordinating activities to completion.Responsibilities of the SENIOR MECHANICAL ENGINEER: Provide technical leadership on new and complex initiatives for the development and commercialization of energy-based devices at Pentax. Create concepts, prototypes and detailed design of new energy-based diagnostic and therapeutic devices and/or for significant product changes to existing products. enhancements Develop design inputs, including marketing requirements and design specifications, with associated justification for new product development. Work with physicians and product management to define elegant technical solutions to clinical problems. Lead risk analysis and risk management activities including human factors studies; create risk assessments, risk management plans and risk management reports. Participate in animal and clinical studies; travel as needed. Conduct research and publish as appropriate. Approve designs, test protocols, and reports. Responsible for adhering to design controls and documenting all product development work in a Design History File. Justify new product development and develop project plans and budgets. Conduct business development research and due diligence activities as directed by supervisor. Create presentations to senior leadership for design project updates and milestones reached. Comply with FDA/Other-markets Regulation and Guidance as required for Pentax Medical Design Controls systems. Other technical, design documentation, DHF documentation and project management tasks as defined by supervisor. Other duties as assigned by managementMinimum Qualifications of the SENIOR MECHANICAL ENGINEER : BS or MS in Mechanical Engineering (3+ with MS) or (5+with BS) years of experience in mechanical design Experience in the medical device field strongly preferred Interventional catheter experience a plus Experience in cryo-ablation and designing with small amounts of cryogenic gases a plus Complete knowledge of Design Control & Quality Systems Proficiency in CAD software and 3D Printing. Able to take product from concept through production release Ability to manage multiple projects and competing priorities Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc. Strong verbal and written communication skills Agile experience desirable Knowledge of ISO/FDA regulations preferredIt is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.