Sr. Mechanical Engineer
Purpose and Scope
The Senior Mechanical Engineer is responsible for the design of mechanical components and coordinating all associated activities such as testing, documenting and design reviews. They act as the primary mechanical designer on the interdepartmental project team. This role is relied upon to be a technical resource for junior engineers in regard to mechanical design. They are also responsible for the development of requirements, DFMEA’s, drawings and 3D CAD models.
Primary Organization Responsibilities
- Create / improve mechanical designs for the Disposable Team
- Responsible for the Mechanical portion of the Device History File for Disposable Team
- Mentor junior team members to improve their design abilities
- Create product requirements and develop risk analysis
- Order samples, build and test prototypes
- Host design reviews
- Assist with complaint investigations, CAPA’s, IN’s and any other consumable product related issues
- Assist with verification testing related to disposable products
- Perform other duties as directed or assigned
Personal Qualifications and Experience Education/Experience
- Bachelor’s degree in engineering or related field is required. Advanced technical or management degree preferred.
- Minimum 5 years of experience in medical device manufacturing and process development. (Specific experience with Class 2/3 devices is preferred).
- Possess strong organization, engineering, analytical and communication skills
- Be comfortable in a fast paced, evolving, and entrepreneurial organization
- Set a fast pace for the organization
- Experience with CAD software
- Experience with injection molding, machining and 3D printing is preferred
- Possess the ability to be able to build product as required