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

Summary: Responsible for maintaining and supporting production needs on a daily basis. Develops and executes process validation plans (IQ, OQ, PQ), protocols and reports. Responsible for maintaining the “Process Failure Mode and Effects Analysis” (PFMEA) document for the products. Works concurrently with R&D and external vendors to design and develop manufacturing processes and equipment. 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. Train production operators / product builders according to the work instructions. Develops and implements measures that improve product quality (yield improvement, complaint reduction) and drive cost savings (labor, material and overhead).

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

• Provides product and process DFM (Design for Manufacturing) input to R&D Engineering to improve the manufacturability and help reduce the product cost.
• Implement efficient processes capable of consistently high yields.
• Analyze the new processes through FMEA and POKA-YOKE techniques.
• Support completion of the required process IQ, OQ, PQ elements of process validation.
• Lead the efforts of in addressing CAPAs and NCRs for the product and material failures.
• Debug, establish process parameters, and then qualify new tooling for production utilizing Design of Experiment (DOE) techniques when required.
• Provide technical support in the resolution of product complaints and/or safety issues. As required, serves as leader of a failure investigation.
• Identify root causes of manufacturing process nonconformities using Six Sigma techniques. Identifies and implements the necessary actions to correct and prevent the recurrence of nonconformities through the Corrective and Preventive Action Process
• Mentors and sets project tasks for Mfg. Engineers on their specific project team and on other teams as needed
• Maintain documentation of processes and train product builders accordingly.
• Leads cross functional project teams. Major objectives may include: improving manufacturing operational efficiency, qualifying replacement components, improving product quality, improving customer satisfaction, and reducing manufacturing costs.
• Continuously improves safety, quality, lead time, productivity, and cost of existing manufacturing processes by implementing Lean Manufacturing principles and coordinating Kaizen events.
• 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.
• 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.
• Work with the R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.

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.
• Experience in quality systems, CAPAs, NCRs
• Ability to plan and implement projects from concept to completion.
• Ability to juggle multiple and shifting priorities and projects.
• Ability to develop test methodologies.
• Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word)
• Working knowledge of FDA QSR’s and ISO guidelines.
• FMEA experience is required.
• Lean Manufacturing and Six Sigma knowledge is required.
• Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003.
• Good understanding of Lean manufacturing principles.
• Six Sigma training required.

B.S. or M.S. in Manufacturing, Mechanical, Bio Medical, Chemical or Industrial Engineering or a related field.

A minimum of five years of medical device manufacturing experience (mid volume, complex disposable device manufacturing).

Must have mid-volume, device manufacturing experience.

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]