Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.
Our Dynamic Process Engineering team, which plays a vital role in our Global Operations is currently hiring for a Process Engineer who will be responsible to set up new process and implement process controls to comply with Quality requirements. You will provide support on daily operations to meet targets in terms of process yield, production output, product NPI based on the agreed plan.
You will specifically be expected to:
- Ensure product and process quality meets specifications required
- Poka Yoke (error proofing) where possible to prevent errors
- Investigate production and process issues providing technical support and training
- Creation and maintenance of Engineering/Product work instruction to ensure Operative compliance
- Coordinate and work with external Manufacturing team to drive and meet daily planned output.
- Working with external and internal Manufacturing teams to maintain Process flow, Control Plan, PFMEA, Operation and Maintenance with proper documentation.
- Working with external team to support assets/equipment inventory.
- Responsible for new products or processes setup, test deployment and process validations and follow ups of activities.
- Conduct failure analysis on production and process related issues.
- Execution of containment and corrective action implementation on non-conforming product
- Working with external team 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
- Bachelor Degree in Electrical/Electronic/Mechatronics Engineering
- 3 – 5 years of working experience in manufacturing, preferably in Medical Device Manufacturing
- Possess experience in Product Functional and Acoustic testing
- Knowledge of the use of proprietary statistical software (e.g. Minitab, JMP)
- Experience with process FMEA, Quality Control tool and Failure Analysis technique (e.g. Design of Experiment, Fishbone diagram, 5 why analysis)
- Knowledge of FDA Process Validation Guidance
- Experience with regulatory audit, in either ISO 13485 or FDA CFR Part 820
- Knowledge of cGMP and good documentation practices
- Proficiency in Microsoft Office Tools