Collaborate closely and cooperatively with process development, design assurance, manufacturing, regulatory, clinical, and marketing cross-functional partners to ensure project success.
Work independently to plan and schedule your own activities, which are necessary to meet timelines.
Demonstrate attention to detail and critical thinking through completion of high-quality deliverables. Demonstrate clear and effective verbal and written communication.
Ensure compliance with relevant regulatory requirements and standards.
Conduct feasibility studies, develop prototypes, and perform testing to optimize product designs. Summarize, analyze, and draw conclusions from test results. Communicate results and insights to technical community and recommend further steps to stakeholders.
Perform troubleshooting related to design, material, and/or process.
Create concepts for existing products and present ideas.
May design, procure, and fabricate tooling and fixtures.
May train and/or provide work directions to technicians.
Responsible for design related documentation including prints and specifications.
Demonstrates design control & PLCP knowledge through generation of high-quality deliverables.
Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process.
Maintain product performance through Quality Investigations and ensuring rigorous support for design changes.
Interfaces with vendors and physicians where projects require.
May train and/or provide work direction to engineers, technicians and interns.
Required qualifications:
Bachelor's/Licenciature Degree: Mechatronics, Mechanical, Materials Science, Electromechanical, Chemical Engineering or related field.
English level: +90%.
Required minimum years of work experience (primarily in medical device or related field): 7+ Years
Please Submit Resume in English.
Preferred qualifications:
Expertise in providing technical leadership in design and development.