**Job Title: Product Development Engineer III**
- Departamento: R&D_
- Reports to: Dir, Product Development_
- Location: Heredia, Costa Rica_
**JOB SUMMARY**:
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).
**Education and Experience**:
Bachelors or higher degree in Engineering or Industrial Engineering, Chemical Engineering, or related
degree.
Master's degree Desirable
Minimum 5years of experience in areas such as Product Development, Manufacturing, Process
Engineering or Quality in Medical Device Industry.
Fluent English Speaker (Advance >90%)
Knowledge Quality Management Systems/Regulations (GMP, QSR, FDA, CAPA, ISO)
Microsoft Office, Minitab desirable, Solidworks or AutoCAD desirable.
Medical device, manufacturing experience required, and design control knowledge and development
process knowledge are preferred.
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.
Risk Management knowledge including FMEA, desirable.
Knowledge on equipment qualifications and process validations.
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