Regulated Product Engineering Specialist

Vor 2 Tagen


Baar, Zug, Schweiz Randstad Vollzeit
Company Overview
Our client is an international, innovative company specializing in wound healing solutions and products. They are seeking a skilled Project Engineer to join their team in the Supply Chain & Quality department. The successful candidate will have a strong background in mechanical design, materials, analysis, and manufacturing, with experience in plastic part design, materials, analysis, and manufacture. Additionally, they should have knowledge of sterilization and biocompatibility medical processes and medical product or regulated environment experience. If you have ASQ certifications, it's a plus Also, you must be proficient in both English and German language.

Job Description
The Project Engineer will work on various projects, including preparing design options, identifying performance trade-offs, and implementing corrective actions. The engineer will also be responsible for documenting product and performance requirements, adhering to regulatory standards such as ISO, FDA, MDR, and MDD. This position requires a minimum of seven years of experience in engineering, with a Bachelor of Science (BS) degree in Engineering or a related field. In addition, the ideal candidate should have electro-mechanical design, analysis, and manufacturing experience, as well as six sigma certification.

Work Environment
The successful candidate will work full-time in a home office setting with up to 30% travel, including occasional international travel. The physical demands of this position require occasional lifting and/or moving up to 50 pounds.

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