The Senior Mechanical Engineer, Manufacturing will be responsible for supporting projects related to our Womens Health and Cancer, Molecular and Micro Diagnostic devices.
Responsible for the support of the production lines within the Instrument manufacturing plant.
- Participation in the design and development efforts of the mechanicalengineering team on multi-disciplinary projects to produce technically sound medical instrumentation. Follow established development processes to meet project schedule milestones.
- Participation in design reviews and product Core Teams. Assess the ability of proposed designs to meet specified requirements, including manufacturability. Interact closely with software, systems, and electricalengineering functions to develop comprehensive solutions to design problems.
- Project Management leadership in areas focusing on design changes, process improvements, outsourcing, material cost reduction, and other plant efficiency efforts.
- Troubleshooting assembly and/or general manufacturing issues on the production lines. This includes, dispositioning discrepant material / assemblies, rework evaluation and implementation, deviation waiver generation, and corrective and preventative action efforts.
- Generating Engineering Change Orders to update part specification in accordance with manufacturing requirements
- Participation in Lean initiatives to drive plant efficiency and reduce product cost
- Design and implementation of manufacturing tools to assist in the assembly of products
Additional responsibilities include:
- Detailed design work of subsystems and components of instrumentation, using a 3D CAD (Computer Aided Design) system in accordance with department procedures, to fulfill engineering requirements. Apply fabrication process knowledge to ensure manufacturability of the subsystem and components.
- CAPA Execution - Understanding of the process and ability to complete CAPA activities with little guidance from the subject matter experts (SME)
- Generate engineering drawings and specifications to BD standards, including ASME Y14.5M-1994 (American Society of Mechanical Engineers) Dimensioning and Tolerancing.
- Conform to the requirements of ISO 9001 (International Organization for Standardization) and cGMP (current Good Manufacturing Practices) standards for the design and development of medical devices.
- Bachelors degreerequired in Mechanical Engineering or related engineering field
- Minimum of 10 years of relevant experience working in a mechanicalengineering role
- Must have experience working in a FDA regulated environment or highly regulated industry.
- Ability to demonstrate the application of fundamental engineering principles and techniques, including heat transfer, fluid mechanics, and kinematics and dynamics as applied to machine design
Application of Transfer functions during troubleshooting and production support (i.e. Statistical Tolerance Analysis, Design for Six Sigma)
Experience with Process capability (Cp & Cpk) a plus
Fluent in the understanding & application of Geometric Tolerancing
Technical Writing skills as applied to manufacturing documentation and process development
Experienced in the creation and revision of technical documentation.
Agency Compliance (General knowledge) - Familiar with general UL, CSA, CE, and RoHS requirements.
Solid Modeling and drafting experience using SolidWorks & Mechanical Desktop preferred
2D AutoCAD experience a plus
Knowledge of manufacturing processes including machining, sheet metal, injection molding, welding, forging, casting, stamping, etc
Troubleshooting skills relating to electro-mechanical assemblies
Job ID R-23730