Manufacturing Engineer Medical Device - Switzerland
Want to know company name or location? Company managed [?]
- Our company is a research-driven, specialty biopharmaceutical group active in global markets.
- The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics.
- Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Responsible to support Manufacturing and change control activities at subcontractors of products post regulatory approval. Maintenance and review of the technical files.
- Provide technical support on Manufacturing processes for Medical Devices at Subcontractors.
- Support the validation activities (including re validation) for manufacturing processes at subcontractors or within the company Manufacturing Network.
- Lead improvement projects to sustain or improve the quality of the products, reduce the lead time and increase the yield.
- Lead equipment maintenance and replacement projects.
- Where applicable, responsible to perform Design Verification test for Medical Devices where our company is Legal Manufacturer.
- Provide Technical & Manufacturing assistance during change control, complaints management or CAPA activities.
- Maintain technical drawings for small changes. Participate in larger design change projects as technical support.
- Maintain the technical file documentation including the risk management file for products where company is the Legal Manufacturer or for Combination Products in the US Market.
- Maintain Device Master Record for Medical Device where company is Legal Manufacturer.
- Participate in cross functional teams to create and implement manuals, guidelines, tools to facilitate and structure working processes within the company.
Required Experience & Skills
- Degree in Mechanical, micro technical, manufacturing Engineering or equivalent.
- Minimum 5 years’ experience in medical device manufacturing industry with demonstrated manufacturing support experience.
- Good working knowledge within device manufacturing processes, including validation and regulation (EU and FDA).
- Excellent command of English (verbal & written).
- Good communication (both written/verbal) and listening skills; ability to persuade others by using evidence to justify arguments.
- Ability to represent the business to the customer/external stakeholders.
- Preferably, experience with moulding of plastic parts, precision metal components and sterilization.
- Experience design tools e.g. Solidworks.
- Ability to work well as an integral part of a large Project Team, a team player, task oriented and keen on working in a cross-cultural working environment.