Supplier Development Engineer

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna we develop and manufacture diagnostics tests that improve patient outcome all over the world.
This past year, our Solna site has expanded and doubled in size, and we are now continuing our journey of growth in search of a star that is passionate about quality and improving lives of others.
The role
The role Supplier Development Engineer (SDE) is a new function that is being set up here in Solna. The person in this role will be working with the Purchasing Director, and connect with internal functions, suppliers and Cepheid sites in supporting our project teams by assessing supplier capabilities and provide feedback to new supplier selection, evaluation, and qualification during program design changes and development. The scope of the role is to


Create and develop specifications and control plans for new critical parts, plan first article inspections, and identify secondary sources.
Identify requirements for external quality controls and work with suppliers to establish, supervise, and trend key supplier performance metrics. Use data analytics to make recommendations on actions.
Interface between suppliers and internal teams for supplier issues.
Review, approve, and release change orders to suppliers.
Identify, quantify, prioritize, and drive supplier improvement projects including supplier recommended design changes to internal teams.
Review, drive corrective actions, and approve supplier issues.
Coordinate any spec or supplier performance changes and connect with global Cepheid manufacturing sites.

Qualifications
We believe that the successful candidates has a minimum of 3 years of experience of working in a GMP or regulated industry, together with a university degree within Chemical Engineering, or similar. We put great emphasis on personal suitability and in particular the ability to able to take ownership, being adaptable, having a positive approach when it comes to tackling and resolving problems in a timely manner. This in combination with the following experience will improve your chances of qualifying for the role:


Proficient in English, both verbal and written communication skills
Experience of and comfortable with executive level presentations
Familiar with Design Control, ISO and GMPMD requirements
Proven experience working multi-functionally and with suppliers on a regular basis
Proven experience with high volume reagent/controls manufacturing processes – automated processes, manual assembly, and functional tests. Experience with pFMEAs and Control plans, and technical quality assessment.
Proven experience with production line setup, validations, qualifications, and working with contract manufacturers
Understanding of processing limitations and design characteristics
APICs certification
Proficiency in MS Excel, MS Power Point, Agile, and SAP
Ability to read and interpret product Bill of Materials (BOM's)
Adaptable self-starter, critical thinking skills, and can tackle problems under pressure
Some travel domestically and internationally is required (15%)

What we offer
We offer you to be a part of a fast-paced and fast-growing, but yet friendly and diverse company, where you will find it meaningful to go to work. We take ownership in caring for our employees, and also offer a wide range of benefits, which include a competitive salary, additional days of leave, a fitness grant, a local gym, etc. Together we work hard to make a difference.
We are interviewing continuously, so make sure to submit your CV today so that we can get to know you!