**PURPOSE STATEMENT***
Lead/Collaborate/Execute product and process development projects (NPI and MPS) from the R&D function.
Develop, collaborate and evaluate new materials, new products/processes or modifications to existing products/processes, as well as analysis and measurement methods, from Design Validation and Verification (DVV) to Process Validation, including the design manufacturability through the development phases (GPF).
**MAJOR RESPONSIBILITIES**
- Perform the local and/or global role of Product Development in the Global Breast team (Global Core Team) for MPS (Marketed Product Support) and/or NPI (New Product Introductions) projects.
- Lead/Collaborate processes/product development for NPI (New Product Introductions) or MPS (Marketed Product Support) projects, as part of the Development Sub-Team. It is considered a key member of the Design Team.
- Lead/Support pre-concept and other research efforts for plastics franchise, including but not limited to product, process and test methods development.
- Collaborate with the other engineering functions on site for transformation projects, providing technical knowledge to find solutions for each need.)
- Support/lead technical efforts or projects related to product design, especially when they are linked to regulatory agencies responsibilities, or to submit special requirements for a new or existing product.
- All other functions inherent to the position such as supporting change control, audits, CAPAs, complaint investigations, Regulatory and Marketing inquiries and related testing or data generation, and other tasks as assigned by the immediate superior.
**QUALIFICATIONS**
**EDUCATION**
- **Bachelor's or higher degree** in Mechanical Engineering, Mechatronics, Product and Tool Design, Mechanical Design or related field.
- Master's degree Desirable
**SKILLS**
- **Fluent English Speaker (>80%) B2/B2+**:
- **SolidWorks certification required**:
- **CSWA certification required**:
- CSWP desired
- Medical device, manufacturing experience required, and design control knowledge and development process knowledge are preferred.
- Knowledge Quality Management Systems/Regulations (GMP, QSR, FDA, CAPA, ISO)
- Microsoft Office, Minitab desirable, or AutoCAD desirable.
- Finite elemental analysis desired
- Risk Management knowledge including FMEA, desirable.
- Knowledge of plastics / rubber parts / silicone design and processing methods preferred.
- Knowledge of materials design, materials testing, and related physical / chemical characterizations of material properties is preferred.
- Technical writing skills.
- Knowledge of equipment qualifications and process validations.
- An understanding of the principles of Design for Manufacturability and testability is preferred.
- Ability to function in a controlled environment regulated by FDA GMPs and handle confidential data required.
- Ability to work with flexible schedule to meet deadlines.
**EXPERIENCE**
- **Minimum 3 years of experience** in areas such as Product Development, Manufacturing, Process, Engineering or Quality within the **Medical Device Industry.