Engineer

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Job description

Description:

JOB TITLE: Manufacturing Engineer

DEPARTMENT: Manufacturing Engineering

REPORTS TO: Manager, Manufacturing Engineering

FLSA STATUS: Exempt

GENERAL STATEMENT OF DUTIES:

The Manufacturing Engineer will work to drive manufacturing engineering projects to reduce cost,

improve productivity, and product quality of existing products and processes with a strong emphasis on

Lean Manufacturing. This engineer will support the design and development of processes, equipment,

and documentation to implement new products into manufacturing successfully. This Manufacturing

Engineer must be able to manage cross-functional teams and communicate project progress to

management effectively.

The Manufacturing Engineer will provide technical expertise and manufacturing support for the

evaluation of proposed medical device designs for manufacturability and will be responsible for

developing and implementing process validation protocols and reports (IQ/OQ/PQ). This role will develop,

implement, train, and monitor the effectiveness of engineering systems and procedures to ensure

compliance to FDA, cGMP, and all other applicable agency regulations.

This requires overall coordination of production, scheduling, health and safety, quality assurance,

coaching and development, and continuous improvement activities within the production areas.

Responsible for leading the plant in its mission to meet or exceed all our customer's expectations while

meeting process metrics. The Manufacturing Engineer complies with policies, regulations and values for

safety, quality, environmental and financial standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Evaluate quality control processes and make recommendations for improvements in

production area.

• Analyze production processes, schedules, methods, and other data and then provide

management with reports containing the data and statistics to enable management to

better understand future requirements needed for the manufacturing process.

• Analyze and plan workflow, equipment placement and space requirements to improve

manufacturing efficiency.

• Assures compliance with all regulations and good manufacturing practices.

• Troubleshoots any production problems; assures that machinery, equipment, and facilities

are properly maintained for efficient production; reports any process or equipment

problems to manufacturing engineering manager.

• Drives manufacturing performance to meet schedules that allow for superior customer

satisfaction and high plant efficiency by establishing and executing operating plans and

objectives.

• Coordinate equipment maintenance and repair services and make sure that

manufacturer's procedures and instructions are followed to keep production equipment

operational.

• Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost,

and /or eliminate waste.

• Prepare and execute process validation protocols for injection molds and automation

assembly.

• Prepare and maintain manufacturing work instructions and provide training as required.

• Performs other manufacturing duties as required.

• Act as a subject matter expert or a project lead for manufacturing engineering projects.

WORK ENVIRONMENT:

Performs primarily office activities in a lighted and ventilated area. May be subject to changes in

temperature and exposure to dust. Will be exposed to uncontrolled environmental conditions during

driving. Will work in a normally acceptable office environment, production floor, or warehouse, with

no abnormal hazards or risks. Reasonable accommodations may be made to enable individuals with

disabilities to perform the essential functions

REQUIRED

1. Bachelor's Degree or higher in material science,

biomedical, mechanical, or industrial engineering.

2. Proficient in SolidWorks, Minitab, Word, Excel, and

Project.

3. Minimum of one to two years (1-2) related experience in

an FDA/GMP regulated industry

4. Experience in applying statistical techniques such as

statistical process control, design of experiments, and

problem-solving techniques is required

4. Experience with design, review, execution, and approval

of Installation, Operation and Process Qualification

protocols, and reports (IQ/OQ/PQ)

5. Experience with measuring devices, electromechanical

machinery, and troubleshooting.

6. Experience developing work instructions and training.

PREFERRED BUT NOT REQUIRED

7. Has developed and trained cGMP/GDP to FDA-oversight

companies.

8. Experience in automation programming and

troubleshooting

9. Six Sigma or Lean Six Sigma green/yellow belt

10. Extensive knowledge of the ISO/FDA requirements for

medical devices

11. Master's degree in an Engineering or Science discipline or

equivalent work experience.

12. Experience and competence reading and understanding

drawings, specifications, and performance requirements.

13. Additional class work in management courses, medical

device engineering and problem-solving techniques.

PHYSICAL DEMANDS:

Must possess sight/hearing senses or use prosthetics that will enable these senses to function

adequately so that the requirements of this position can be fully met. Physical activity includes walking,

standing, bending, squatting, reaching above shoulders and lifting up to 40lbs. Must be able to drive

an automobile for short and long distances.

**COVID-19 Vaccine Required**

PI