Primary Responsibilities and Duties:
Note: The following primary responsibilities are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• Research and analyze data such as customer requests and specifications to determine feasibility of design.
• Specify, design and document systems and products such as instruments and disposables, considering performance, patient safety, regulatory requirements, patents, and corporate goals.
• Work closely with other departments to ensure projects conform to all regulatory and quality regulations.
• Interface with electrical and software resources as part of a cross-disciplinary design team.
• Prototype designs using a variety of prototyping methodologies including SLA , RTV molds, FDM, machining, model making, gluing and painting.
• Organize, plan, lead and manage team projects in alignment with project goals.
• Aid in setting the strategy for the R&D department.
• Develop/improve products to ease manufacturing processes.
• Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.
Experience, Education, Training Skills and Traits:
• BS or MSME plus ten years experience designing electromechanical systems.
• Minimum of three years in a medical device environment is preferred. Similarly, highly regulated fields may also be considered such as aerospace.
• Experience with heat transfer and thermal analysis a bonus.
• Five to ten years experience designing using CAD, preferably proficient with Pro/E.
• Proven track record of successful product development using a variety of design tools and prototyping techniques.
• Working knowledge of project planning and management including use of PM software such as MS Project.
• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.
• Strong team-working and communication skills.
• A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
• Competent using office software including MS Word, Excel, Internet Explorer and Outlook.
