Manufacturing Engineer

MANUFACTURING ENGINEER (EU MDR)

For one of our clients, specialized in the MEDICAL DEVICES AREA BASED IN THE SOLOTHURN AREA we are looking for a Packaging Engineer.

This is a challenging, CONTRACTING POSITION, STARTING IN JULY UNTIL THE END OF THIS YEAR (extension possible).

Project description:
By May 26th, 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR). You will liaise with all key stakeholders when formulating and communicating the Project Plans and ensuring continual deployment of the MDR Plan through consistent excellence in project management.

YOUR RESPONSIBILITIES:

- Leads 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).
- Performs 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.
- Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
- Participates in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and other sites.
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture

YOU BRING TO THIS ROLE:

- 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
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- Master of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
- Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
- Demonstrates strong written, verbal and presentation skills.
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Demonstrates positive interpersonal skills and professional interactions with cow

If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application! If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte.