Mechanical Engineer Ii

This Mechanical Engineer II will use creativity and accepted engineering practices in the design and analysis of machine and component designs primarily suited for use in medical devices. Mechanical development work is iterative and enduring with significant expectations placed on documentation. The position is responsible for the selection of approach, materials, methods, and means for approving and validating output.

Primary Duties & Responsibilities:

Technical Development and Analysis

1. Designs, develops, prototypes, measures, and tests mechanical components used in electro-mechanical, software-controlled devices and related disposable kits primarily used in medical imaging segments.
2. Cooperates with and understands the design challenges being addressed by other project team members and product managers, and goes forth in designing medical/patient care solutions and products that are suited for ease of manufacturing, assembly, service, and use using DFx principles while meeting the needs of the customer.
3. Effectively utilizes knowledge of materials and manufacturing processes to create and maintain documentation suitable for manufacturing transfer and regulatory submissions.
4. Designs FBD of mechanical systems and uses them to guide analysis of models and function of mechanisms.
5. Provides hands-on development and support from product conception to end of life.
6. Maintain skills and awareness of technical improvements and competition advancements.

Project Management and Documentation

1. Rigorous documentation for all phases of product development, including design specifications, verification test plans, project schedules, CAD models, drawings, and change orders associated with medical devices and consumable products.
2. Routine communication with peers and supervisors including documentation of work, meetings, and decisions.
3. Maintain project plans, set/adhere to milestones, deliverables, and budgets, and may manage a limited number of concurrent projects primarily of a mechanical scope and consisting of 1-2 designers or technicians.
4. Ensure that team meetings, project reviews, and action lists are kept current and communicated to all stakeholders in a timely fashion.
5. Direct outside contract personnel as needed for completion of specific tasks.

Quality, Compliance, and Regulated Practices

1. Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
2. Designs products to meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by product management.
3. Participates in the selection of vendors and fabrication sources to assure quality and compliance to released specifications.
4. Committed to fostering and driving an environment and work output based on continuous improvement