Job Title: Manufacturing Manager
Reports To: VP of Operations
FLSA Status: Exempt
Department: Operations

Summary: This position is responsible for managing production activities, including training of operators, production scheduling and accuracy/completeness of production documentation and ensuring the proper maintenance of the Production area and installed
equipment. Responsible for insuring the production area and its personnel are in compliance with GMP’s, applicable ISO and FDA quality system standards.

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 products utilizing Design for
Manufacture and Assembly technique.
• Coordinate quoting activities for the manufacturing processes developed
• Develop highly efficient (95% or higher) processes capable of consistently high yields. Analyze the new process through FMEA and
POKA-YOKE techniques
• Specify, order, and track progress of tooling from design through tool build facilitating solutions to problems as they occur
• Assist Mfg. Engineering to Debug, establish process parameters, then qualify new tooling for production utilizing Taguchi/DOE
techniques when required
• Contribute to the intellectual property position of the company via invention and patent applications. Maintain accurate documentation
of concepts, designs, drawings, and processes.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments.
• Provide engineering and technical support of products introduced into both the domestic and international markets.
• With supervisory assistance, procure and oversee outside suppliers and consultants as required.
• Ensure that Maintenance of Quality System Records, including pre-production quality assurance procedures, pre-clinical testing
programs, and post production QSR compliance in coordination with the Document Control, Regulatory/Clinical, and
Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues
• Provides training for work center personnel on Standard Operation Procedures and Work Instructions for new processes and
• 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.
• Responsible for design, 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.
• Review and recommend designs for production fixtures and tooling.
• Prepare and maintain documentation requirements to support and control manufacturing processes using Statistical Process Control
• Determine, train, and enforce, through functional groups, document control requirements in order for the company to meet internal
and external needs. Evaluate and develop improved techniques for the control of documents.
• Assist Engineering in evaluating capital equipment investments.
• Provide manufacturing engineering expertise to the efforts of Purchasing, Quality and R&D Departments during vendor qualifications
and evaluations, including vendor audits.
• Assist and mentor Manufacturing Engineers.
• Responds to Product Evaluation Studies using the Voice of Customer techniques and inputs in order to identify and define the most
beneficial product and process improvement projects for organization.
• Schedule and coordinate disposable production and sterilization.
• Monitor and update disposable production schedule.
• Provide manufacturing metrics.
• 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.
• Ability to work with cross-functional teams, problem solve and drive solutions to meet internal and external customer requirements.

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

• Demonstrated ability to lead and manage a manufacturing team
• Demonstrated leadership and team building skills
• Ability to interface with customers, problem solve and drive solutions to meet customer requirements
• Thorough understanding of the design of mechanical components and assemblies
• Thorough understanding of assembly methods and equipment required for the manufacture and packaging of medical devices.
• Good understanding of electromechanical and electronic devices and their applications, an understanding of statistical methods, and
ability to plan and implement projects from concept to completion.
• Knowledge of metal and plastic design requirements, material selection and fabrication techniques is required. Ability to develop test
methodologies is required.
• Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word)
• AutoCAD and SOLID WORKS experience also required.
• Working knowledge of FDA QSR’s and ISO guidelines.
• FMEA experience is required.
• Lean Manufacturing and Six Sigma knowledge is preferred.
• Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003
• Knowledge of electronic document system, Agile is preferred
• Knowledge of various ERP systems, PDM Works.

B.S. or M.S. in Manufacturing /Industrial Engineering or related discipline or equivalent work experience.

A minimum of 10 years experience in cGMP/FDA regulated industry.

At least 3-5 years experience managing a team.

Supervisory Responsibilities:
This job has supervisory responsibilities for all Clean room personnel

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]