Main Purpose of Job:
Bring technical support to the injection molding & sales area.
Main Job Duties/Responsibilities
- Bring support in the planning, developing, implementation and coordination of new molding development activities as well as in the changes to existing manufacturing processes related to the molding area.
- Prepare validation protocols and reports, work instructions and any applicable documentation required to sustain manufacture.
- Bring support in qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, OQ and PQ).
- Bring support in equipment, molds and materials specifications for new molding processes, existing processes, or existing process changes, ensuring part designs can be injection molded economically and reliably. Provide support in cost estimation & timing for the procurement of capital equipment.
- Initiate Device History Record (documentation required for manufacturing)
- Troubleshoot existing molding processes for quality issues typical to the injection molding industry.
- Participate in the analysis of new and existing manufacturing processes and recommend improvements to maximize quality and productivity. Implement approved recommendations by fabricating custom fixtures, creating necessary documentation, directing efforts of outside resources.
- Training of Molding and Quality Assurance personnel on proper use of fixtures and molding process.
Job Qualifications Requirements (What is absolutely required to do this job)
Knowledge / Education
- Senior student BS in Engineering or related field.
- Knowledge on ISO 13485 and knowledge on CRF 820 CGMPs (desired).
- English 80%
Job Experience
- From 0 to 1 year work experience; It is a plus experience in a Medical Device Company
Skills / Competencies
- Project Management.
- Customer Focused Quality.
- Quality Engineering Statistical Tools.
- Reliability Engineering Statistical Tools.
- Influence Management.
- Working knowledge of statistical techniques.
- Working knowledge of quality and reliability software.
- Ability to work in a team environment.
- Working knowledge in spreadsheets, databases and word processing software programs
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on Linked In.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.