Improves product design or designs new product using engineering principles and achieves expertise in mechanical engineering. The Mechanical Engineer is responsible for running design controls and designing Mechanical product/subsystem release solutions.
Duties include (but are not limited to):
1. Designing new products and/or supporting product quality improvement for disposable products for bioprocessing application.
2. Executes design to engineering standards. Write design verification/validation plan, perform testing and write verification/validation report.
3. Works within a team to deliver technical solutions.
4. Works with technical leadership and cross functional team to ensure that the technical deliverables meet the product specification.
5. Seeks mentoring to learn and solve problems
6. Leading design visualization efforts with 3D CAD models and essential component and assembly details to explore multiple design options
7. Developing engineering design concepts for components and disposable systems that have demanding requirements for regulatory compliance, reliability and cost
8. Engaging in all phases of product redesign for improvement or new product development, including concept, prototype build, test, documentation, supplier interfaces, manufacturing introduction.
9. Conducting analysis of existing and new product reliability using FMEA, risk management and DFR.
10. Developing innovative designs to meet all requirements for performance, reliability, cost and manufacturability.
11. Maintain and develop competence required for the job
1. BS in Mechanical Engineering, or Biomedical Engineering
2. Knowledge in structural engineering, plastics molding, analysis, and verification of mechanical structures.
3. Understanding in theories, concepts and techniques in structural and/or dynamics analysis
4. Knowledge of industry and/or academic practices and standards related to structural analysis, finite element analysis, and structural verification testing, bioprocessing.
5. Knowledge in statistics analysis, risk management and FMEA.
Quality Specific Goals:
1. Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
2. Demonstrated design verification and validation and product design experience.
3. Self-starter, energizing, results oriented, and able to multi-task
4. Excellent teamwork, coordination and communication skills
5. Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets
6. Effective oral and written communication skills
7. Global project experience---