What are the responsibilities and job description for the Design Engineer position at RAMPART ic?
JOB OVERVIEW:
The Design Engineer is responsible for the development, design, and improvement of medical devices and related components. This role involves creating detailed 3D models, engineering drawings, and technical documentation to support manufacturing, assembly, and product development. The Design Engineer will work closely with cross-functional teams, including engineering, quality, operations, and manufacturing, to ensure products meet industry standards, regulatory requirements, and customer needs. This role requires strong problem-solving skills, mechanical aptitude, and a commitment to continuous improvement. The Design Engineer reports directly to the Vice President of Operations.
JOB RESPONSIBILITIES AND DUTIES:
Consistently models the core values of the company both internally and externally.
Openly commit to and support company processes and systems.
Understand and follow the processes of the Rampart Quality System.
Design and develop medical device components, assemblies, and systems using CAD software (SolidWorks)
Generate detailed engineering drawings, bills of materials (BOMs), and technical documentation to support manufacturing and quality assurance.
Perform engineering calculations and analyses to ensure designs meet performance, safety, and compliance requirements.
Collaborate with cross-functional teams to refine designs, address manufacturing concerns, and optimize product performance.
Participate in design reviews, feasibility studies, and risk assessments to ensure design robustness and manufacturability.
Develop and prototype new product concepts, conducting testing and validation to verify performance.
Work with suppliers and manufacturing partners to ensure design feasibility, cost-effectiveness, and efficient production.
Maintain accurate and detailed design records, ensuring traceability and compliance with regulatory requirements.
Support continuous improvement initiatives by identifying design enhancements and process optimizations.
Ensure compliance with industry standards, including ISO, FDA, and Good Manufacturing Practices (GMP). Any other duties as required by the supervisor.
KEY METRICS:
Design Cycle Time: Measures the time taken from initial concept to final design approval.
Documentation Completion Time: Evaluates the time taken to complete documentation for manufacturing and regulatory compliance.
Compliance Rate: Ensures adherence to regulatory and quality standards.
QUALIFICATIONS/EDUCATIONAL EXPERIENCE:
Technical Skills: Proficiency in CAD software (SolidWorks preferred), engineering analysis tools, and product design principles.
