2018-06-06

Manufacturing Engineer - Medical Device
Job Opportunity at Excelsior Recruiting Group

Posted on Jun 6

http://www.excelsiorrg.com/    (678) 304-9860

Location: Park Ridge, NJ
Job Type: Full Time
Job ID: W4161137

Driven by a commitment to research, quality and service, company provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

 

We have several locations across the US and are looking for new Associates to join our team!

 

POSITION PURPOSE

 

The Sr. Manufacturing Engineer is responsible for technical support of plant operations in an FDA regulated environment. This position will contribute towards improved manufacturing efficiencies and reduced scrap by utilizing continuous improvement techniques. This is a hands-on position which will provide key technical support throughout the Operations. This person will also take a leadership role in engineering functions such as specifying new equipment and materials, troubleshooting processes, and identifying and implementing process/product improvements.

 

We are looking for a background in Industrial Engineering for this role.

 

ESSENTIAL FUNCTIONS AND BASIC DUTIES

 

1. Identify opportunities and implement changes to reduce variation and improve scrap rates and productivity

2. Develop manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.

3. Leading and participating in projects, JDIs (Just Do Its), kaizens, and utilizing Lean Six Sigma tools to improve processes.

4. Provide support to R&D, manufacturing, marketing, and customer service; interface with customers and suppliers

5. Using six sigma principals, identify key process parameters and develop monitoring tools to enable cost reduction efforts

6. Manage projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project

7. Drive capacity improvements by identifying and executing continuous improvement projects

8. Mentor and coach team engineers in developing new products and technologies

9. Support design and process FEMA’s

10. Implement cost reduction or cost avoidance by working closely with manufacturing

11. Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.

12. Support validation when necessary by authoring and executing validation protocols and summary reports for equipment qualifications, process and packaging validation, and cleaning validation processes to ensure regulatory agencies compliance

13. Design, develop and execute line trials (DOE) and summarize data.

14. Participate as Subject Matter Expert (SME) in the New Product Development Process.

15. Create and maintain strong relationships within the organization to foster awareness and achievement of continuous improvement goals.

16. Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities.

 

PERFORMANCE MEASUREMENTS

1. Successful and timely completion of manufacturing engineering and continuous improvement projects

2. Successful audit outcomes by internal and external auditors and regulatory agencies

3. Achieve or exceed cost savings targets

Requirements   QUALIFICATIONS

 

5-7 years of experience in industrial engineering and process improvement are the most important requirements for this role.

 

EDUCATION/CERTIFICATION:

Bachelor’s Degree in engineering discipline. Industrial, Mechanical, Electrical, or Automation Engineering preferred

 

REQUIRED KNOWLEDGE:

-Thorough understanding of electro-mechanical systems with an ability to diagnose and eliminate in-efficiencies

-Good working knowledge of manufacturing methods, and an ability to effectively persuade people of all different levels within the organization

-Ability to troubleshoot equipment problems and perform complex system tests

-Familiar with the design controls, FDA and ISO regulations (cosmetics, drug, and medical device), and GMP practices

-Relies heavily on experience and judgment to plan and accomplish goals

 

EXPERIENCE REQUIRED:

-7 or more years of experience in FDA or ISO regulated facilities in manufacturing engineering or continuous improvement

-Experience with line integration automation, PLC programming, and controls system a plus

 

SKILLS/ABILITIES:

-Experience with lean six-sigma manufacturing and preferably, green-belt certified

-Innovative and Critical Thinking skills

-Excellent verbal and written communication skills required.

-Skilled in technical project management.

-Excellent problem solving and interpersonal skills.

-Proficient in Microsoft Word, Excel, PowerPoint, Mini-Tab (or equivalent)

 

 

WORKING CONDITIONS

 

NONE: No hazardous or significantly unpleasant conditions.

 

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