imds: Innovative Medical Device Solutions
Senior Product Development Engineer Phoenix, Arizona
Under the guidance of an Engineering Manager, the Senior Product Development Engineer plans and executes tasks associated with medical device product development, including but not limited to: project planning, design, analysis, testing, and documentation. In addition, the Senior Product Development Engineer will be expected to directly communicate with Partners to effectively accomplish project tasks.
Key Roles and Responsibilities:
Perform moderate to advanced product development tasks in accordance with SOP‐06 with moderate guidance:
• Identify design requirements and generate novel engineering solutions
• Conduct market and intellectual property research and analyses
• Produce robust engineering models and drawings using SolidWorks
• Perform engineering analyses such as stress, FEA, basic failure analysis, tolerance stack, material selection and FMEA.
• Apply a working knowledge of relevant manufacturing processes to optimize Design for Manufacturability
• Develop and execute test protocols, interpret results, and publish associated reports
• Create and maintain Design History Files in accordance with established IMDS Product Development Process
• Organize and participate, as appropriate, in cadaver labs, surgeries, industry conferences, and other product development related activities
• Participate in and/or lead design review and/or design transfer activities
• Perform effective time/project management activities
• Participate in and/or lead project management tasks such as regular planning events, partner
communications and resource coordination.
• Provide technical and project related direction and instruction to product development team members.
• Draw upon external resources for expertise as necessary
• Participate, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives
• Lead effective communication efforts with internal and external stakeholders regarding status, timing, budgetary and design issues impacting the project.
• Build and maintain effective relationships with internal and external stakeholders.
• Create and deliver project presentations to internal and external audiences
The following points outline the knowledge, skills, and abilities required for the position of Senior Product Development Engineer:
• Bachelor’s degree in Mechanical or other related Engineering disciplines and 5 years relevant design experience, OR Masters degree and 4 years experience, OR PhD degree and 3 years experience.
• Prior experience with orthopedic medical device development is preferred.
• Demonstrated ability to leverage manufacturing process and material knowledge in engineering designs
• Proficient in solid modeling. Experience with Solidworks is preferred.
• Proficient with Microsoft Office applications, including Word, Excel, PowerPoint and Project.
• Demonstrated ability to successfully manage projects from planning to completion
• Basic Knowledge of Anatomy, Physiology and Biomechanics is preferred.