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Methods Engineer

Company Description

In the context of an increase in activity, one of our clients, an international company specialized in the development and manufacture of biomedical products, is looking for a Methods engineer for its Swiss office based in the canton of Vaud.

Job Description

As Methods engineer, your main role will be to be responsible to evaluate existing processes to improve it, reduce cost and develop best practices. Develop and implement innovative solutions while maintaining reliable, safe, high-quality of products. Develop a culture of continuous improvement by innovative solutions. As part of the matrix organization, participate and validate transversally the manufacturing transfer of new products or processes projects.

Your main responsibilities will be focus on manufacturing processes improvement, project management, risk management and problem solving.

 

Your main tasks :

– Identify, evaluate, and improve existing manufacturing processes

– Work on teams to improve manufacturing processes/products and enhance their robustness

– Manage the design and execution of manufacturing processes

– Develop and approve documentation to support improved manufacturing processes

– Assure methods project tasks are accomplished within defined timelines, procedures, objectives, budget and required safety/compliance standards

– Provide support to new product introduction, production process development, product transfers, new equipment introduction and existing process sustainment

– Write and perform Validation plan strategy and process validations in collaboration with Quality Validation team including methods for inspection

– Participate to Risk process analysis and propose appropriate recommendations to mitigate risks

– Guarantee continuous improvement and LEAN tools and methods

– Manage Change Control for processes and equipment improvements

– Support Manufacturing in the solving of manufacturing issues

– Conduct investigations, evaluations and make recommendations

– Manage CAPAs

Profile

To lead this mission, we are looking for a profile with:

– Engineering degree or equivalent, with at least 4-5 years confirmed experience in process improvement activities and project management

– At least 6+ years of experience in production support, process definition and development, design, scale-up, improvement and validation

– lndustrial experience working in a GMP compliant setting

– Experience with regulatory filings for Medical Devices and supporting regulatory inspections

You speak English and French fluently, you enjoy teamwork and you are an excellent communicator. You are able to work to tight deadlines and are able to work independently. 

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