Engineer II, Manufacturing Engineering

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

·        Assist and evaluates manufacturing processes by conducting necessary line audits or validation through applying knowledge of product design, fabrication, assembly, tooling, and materials; with communication with vendors and gather input and observations from operators.

·        Validate manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.

·        Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.

·        Improves manufacturing efficiency by analysing and planning workflow, space requirements, and equipment layout.

·        Process qualifications and validations including equipment qualifications and material specifications.

·        Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.

·        Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.

·        Prepares product and process reports by collecting, analysing, and summarizing information and trends.

·        Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.

·        Conduct proof of concept for new technologies or methodology that will provide potential competitive advantage and the cost benefit to Quasar or Customer.

·        Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Bachelor in Engineering or similar technical field with 2 to 5 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred

• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.

• Proficient in DOE and statistical techniques. Certified LEAN/6Sigma will be preferred.

• Knowledgeable in defining process capabilities and control charting.

• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.

·        Knowledge of FDA, GMPs, ISO 9001, ISO13485 and the Medical Device Directives.

• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.