Senior Mechanical Engineer

Position Summary:

The Senior Mechanical Engineer will participate, and at times provide leadership, in the mechanical design of new and modified electromechanical medical devices as well as their sterile disposable counterparts. Responsibilities of this position include project leadership and execution for all aspects of design and modification including: requirements and specification creation, perform engineering modeling and analyses, develop test methods and fixtures, document and communicate the design internally and externally to suppliers. Significant creativity and experience is essential for this role, using engineering practices in the design, analysis, and verification of components (machined, sheet metal, injection molded, extruded, etc.), assemblies, mechanisms and systems. The Senior Mechanical Engineer must be a self-starter capable of driving challenging projects through a product development process both individually and in coordination with a team. The candidate must effectively communicate cross-functionally as well as up to management.

Primary Duties and Responsibilities:

• Technical Development and Analysis
• Designs, develops, prototypes, measures, modifies and tests capital medical equipment as well as sterile disposables as part of electromechanical equipment development
• Specification and qualification of new mechanical designs
• Designs with knowledge of materials and manufacturing processes and understands the interdependencies/design constraints with other project team members
• Exhibits cooperation and sound judgment in design tradeoffs resulting in reliable designs.
• Design For: Quality, Reliability, Use, Sterilization, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer
• Develop tests for design verification and validation for electromechanical products
• Perform design verification activities
• Simulation of systems as appropriate to assure product performance
• Diagnose the causes of system failures and specify solutions
• Develops intellectual property to maintain competitive advantage

Project Management and Documentation:

• Rigorous documentation for all phases of product development, including system requirements, design specifications, verification test plans, CAD models, drawings, and change orders associated with medical devices and accessories
• Develop & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects
• Develop & maintain verification and validation plans for successful submission to FDA and other regulating bodies
• Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion
• Interface with Operations teams to ensure smooth transfer of products into production
• Direct outside contract manufacturer personnel as needed for completion of specific tasks

Quality, Compliance, and Regulated Practices:

• Support compliance to Regulatory Requirements including Underwriters Laboratories (UL), REACH/RoHS, and other environmental standards
• Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
• Ensures product meets requirements regulated by FDA, MDD, MDR, UL, IEC, CE and other governing bodies
• Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications