Job Title: Manufacturing Engineer
Reports To: Senior Manufacturing Engineering Manager
FLSA Status: Exempt
Department: Operations

Summary: Develops and implements measures that improve product quality (yield improvement, complaint reduction) improve product reliability and cost savings product and process changes influencing labor, material and overhead costs. Responsible for developing and executing process validation (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) plans, protocols and reports. Participates in the creation and maintenance of a Process Failure Mode and Effects Analysis (PFMEA). As required, develops and maintains Process Flow Diagrams detailing production flow, process and tool drawings, Device Master Record Index (DMRI), Process Routers, Bills of Materials, Work and Inspection Instructions. Coordinate with R&D in developing reliable and repeatable manufacturing processes.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Work with Product Design Engineering to improve the robustness and manufacturability of new disposable products utilizing Design for Manufacture and Assembly techniques.
• Continuously improves safety, quality, lead time, productivity, and cost of existing manufacturing processes by implementing Lean Manufacturing principles and coordinating Kaizen events.
• Identify root causes of manufacturing process nonconformities using CAPA and Six Sigma techniques. Identifies and implements the necessary actions to correct and prevent the recurrence of nonconformities through the Corrective and Preventive Action Process.
• Prepare and maintain documentation requirements to support and control manufacturing processes using Statistical Process Control techniques.
• Provide manufacturing engineering expertise to the efforts of Purchasing, Quality and R&D Departments during vendor qualifications and evaluations, including vendor audits.
• Develop highly efficient processes capable of consistently high yields. Analyze the new process through FMEA and POKA-YOKE techniques.
• Responsible for implementation and qualification of new or modified manufacturing and test equipment by identifying the best design option to achieve the design requirements and implementation dates.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.
• Support completion of the required process IQ, OQ, PQ elements of process validation.
• Debug, establish process parameters, qualify new tooling for production utilizing Design of Experiment (DOE) techniques when required.
• Maintain accurate documentation of process changes.
• Provide engineering and technical support of products introduced into both the domestic and international markets.
• Provide support in the resolution of product complaints and/or safety issues. As required, serves as leader of a failure investigation.
• Work with the R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• A general understanding of statistical methods.
• Working knowledge of FDA QSR’s and ISO guidelines Ability to develop test methodologies.
• Ability to juggle multiple and shifting priorities and projects.
• Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word)
• Lean Manufacturing and Six Sigma knowledge is preferred.
• Six Sigma training preferred.

B.S. or M.S. in Manufacturing, Mechanical, Plastics or Industrial Engineering or a related field.

A minimum of one year in medical device industry.

Exposure to complex, mid-volume, plastic disposable device manufacturing experience is preferred.

Physical Demands:
Execute daily tasks in a controlled environment room.

Required Training:
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]