Process Engineer / Sr Process Engineer (Dynamic Process Engineering)

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

Ihre Aufgaben

• Observe daily operations and ensure product/process quality meets specifications required.

• Working with IMI-Engineering on Weekly Process/Test Yield Reporting and drive yield improvement to meet KPI.

• Ensure all technical documentation and procedures are in compliance with ISO 13485 and FDA CFR 21 820.

• Creation and maintenance of Engineering/Product work instruction to ensure Operative compliance.

• Coordinate and work closely with IMI-Manufacturing to drive and meet daily planned output. Working with IMI to support assets/equipment inventory.

• Working with IMI-Engineering and Manufacturing to maintain Process flow, Control Plan, PFMEA, Operation and Maintenance with proper documentation.

• Lead new products or processes setup, test deployment and process validations (IQ, OQ, PQ) until completion.

• Investigate/conduct failure analysis on production and process related issues. Execution of containment and corrective action implementation on non-conforming product

Ihr Profil

• Bachelor Degree in Electrical/Electronic/Mechatronics Engineering or any related Engineering Field.

• 3 - 5 years of working experience in manufacturing, preferably in Medical Device Manufacturing

• Possess experience in Product Functional and Acoustic testing *

  Personal competencies

• Knowledge of the use of proprietary statistical software (e.g. Minitab, JMP)

• Knowledge of Lean and/or Six Sigma methodologies will be advantageous (e.g.FMEA, Quality Control tool and Failure Analysis technique - DMAIC, Fishbone diagram, 5 why analysis, etc.

• Familiar with or prior hands on experience in 3D/CAD modelling software (i.e. AutoCAD/Pro-Engineer/Solid Works etc.) will be advantageous.

• Knowledge of FDA Process Validation Guidance

• Experience with regulatory audit, in either ISO 13485 or FDA CFR Part 82

• Knowledge of cGMP and good documentation practice

• Proficiency in Microsoft Office Tools