Key Responsibilities:
- Assist in evaluating manufacturing processes by supporting research programs, applying knowledge of product design and materials, and collaborating with operators and vendors.
- Help design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
- Support process troubleshooting and refinements to improve product throughput and assembly techniques.
- Contribute to improving manufacturing efficiency by analyzing workflow, space requirements, and equipment layout.
- Participate in process qualifications and validations, including equipment qualifications and material specifications.
- Assist in ensuring product and process quality by supporting the design of testing methods and confirming manufacturing processes.
- Provide manufacturing decision-making information by assisting in calculations of production, labor, and material costs, and reviewing production schedules.
- Help prepare product and process reports by collecting, analyzing, and summarizing information and trends.
- Assist in keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and procedures.
- Support Health & Safety initiatives in assigned areas, including accident investigation and corrective actions.
- Research state-of-the-art process technologies and evaluate their potential benefits.
- Participate in Validation Activities as directed.
- Assist in maintaining compliance with ISO 13485, GMP, and FDA regulations.
Education/Experience and Qualifications:
- Bachelor's degree in Engineering or a similar technical field.
- Up to 2 years of experience in a high-volume production environment experience in medical device manufacturing, particularly catheter production, is a plus.
- Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
- Basic understanding of DOE and statistical techniques.
- Familiarity with process capabilities and control charting is preferred.
- Exposure to writing protocols for validations and qualifications, including FMEA and IQ/OQ documentation.
- Awareness of GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
- Self-motivated and eager to drive change and innovation. Must be comfortable working in a fast-paced environment with minimal supervision.
