Manufacturing Engineer

Manufacturing Engineer

You are an outstanding Manufacturing Engineer with experience in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client, an international pharmaceutical company, is looking for you!

Project:

By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)

Overview:

This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.
Provides direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.

Duties & Responsibilities:

- Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
- Coordinate and Support new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
- Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
- Assists in gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
- Assists in developing fixtures and designing tools and has the ability to express and implement ideas with tool designers.
- Assists in the development of manufacturing and inspection procedures.
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.
- Acts as Subject Matter Expertise in GMP and Process & Machine Capabilities
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the

highest levels of professionalism, ethics and compliance at all times.

Requirements:

- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- 4-6 years of experience in manufacturing and/or engineering is required.
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Six Sigma or Lean Sigma certification or 4 years of experience preferred.
- Experience developing and implementing robust automated manufacturing equipment, preferred.
- Experience with packaging, Laser, and CNC processes and equipment, preferred
- Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy
- Strong interpersonal and diplomatic skills
- Fluent in English

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you.