Job DescriptionDuties include (but are not limited to):
- Leading and managing design change projects to improve product reliability, which includes developing new design specifications, owning the project schedule, working closely with all cross-functional groups, creating project plan and report, performing design update work, and implementing new design(s).
- Conducting root cause analysis for ultrasound probes failed at customers.
- Conducting root cause analysis of ultrasound probes failed during manufacturing process.
- Leading and executing design change and/or supplier transfer projects for cost reduction.
- Design components for released products.
- Developing and releasing Verification and Validation Plan/Report.
- Creating design documents such as mechanical/electrical drawing, purchase specification, and inspection specification.
- Ensuring compliance with Design History File (DHF) and other QMS requirements.
- Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives.
Quality Specific Goals:
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality & Compliance training within the defined deadlines.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Ensure compliance/closure of Regulatory and Quality requirements before approving Engineering Change Order for Design Changes.
- Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives.
Qualifications/Requirements: (Basic Qualifications):
- B.S. in Mechanical Engineering or comparable engineering field
- Experience in mechanical design, project engineering, familiar with plastic, sheet metal, die casting and rubber parts design and process
- Expertise with CAD software (PTC Creo, SolidWorks, Autocad) ability to use advanced features for tolerance stackup analysis, proper requirements definition.
- Demonstrate a leadership of cross-functional project teams and an ability to drive project design plans to completion.
- Five or more years of experience as an engineer in a medium to high manufacturing environment with direct responsibility for process and product design improvement.
- Strong analytical and empirical skills to solve difficult problems including proficiency with Design of Experiments and Statistical Process Control methodology.
- Be able to communicate with cross-functional team members in English.
- Demonstrate a motivated, self-starter attitude.
Desired: (Desired Characteristics)
- Knowledge of UL/ETL/IEC standards and how they apply to designs
- Experience with reliability testing with Weibull Analysis and other Design for Reliability tools will be better
- Working knowledge of Mechanical and Thermal aspects of sub-system design and packaging
- Experience with 2D/3D mechanical computer aided design.
- Product design experience with medical ultrasound probes and transducers.
- Process design and manufacturing experience with medical ultrasound probes and transducers.
Aware of Design Control and Quality Management System.