Sr. Manufacturing Engineer for Mdr Validation
il y a 3 jours
**Présentation**SERES Technologies est un spécialiste de l' ingénierie et du conseil dans la maîtrise des risques nucléaires, pétrochimiques et industriels.
- SERES Technologies est une filiale de Groupe Gorgé, un groupe industriel familial présent dans les industries de haute technologie pour des domaines d' activité particulièrement exigeants (aéronautique, médical, défense, énergie) et dont les métiers s' organisent autour de trois pôles d' activité : les Systèmes Intelligents de Sûreté (ECA Group), la Protection des Installations à Risques (Vigians et Seres Technologies) et l' Impression 3D (Prodways Group).
- Aujourd' hui la Société SERES Technologies se décompose en deux marques:
- La marque Mekkatronix spécialisée dans la conception de systèmes complexes dans les domaines de la mécanique, l’électronique et les systèmes embarqués.
- La marque Seres dont l' activité de défense en profondeur s’articule autour de trois cœurs de métiers:
- L' Ergonomie & Facteurs Organisationnels et Humains avec la prise en compte des problématiques liées à l' ergonomie et aux FOH dans les situations de conceptions d' installations, de soutien à l' exploitant, de démantèlement et de transformation digitale ;
- La sûreté de fonctionnement avec les problématiques liées à l’analyse et l’évaluation des performances FMDS (système, électronique, logiciel, mécanique), de la Sécurité fonctionnelle, de la Durabilité, du Soutien Logistique Intégré (ASL, LCC, EDS) et de l' Asset Management (optimisation performance/coût),
- La prévention des risques (sûreté nucléaire / sécurité) en intégrant les aspects évaluation des risques et des impacts, l' animation et la prévention, le support qualité, la sûreté nucléaire, la radioprotection, la neutronique, la criticité et enfin le confinement.
- La conformité et l' ingénierie des sciences de la vie présents dans les domaines pharmaceutique, des dispositifs médicaux, biotechnologique, de la cosmétique et de l' agro-alimentaire.
**Description**
You will work at a large American group. A good command of English is indeed mandatory for this position.
Job Responabilities:
- Interface with R&D, quality engeneering, purchasing, logistics, production, regulatory, and external vendors to resolve manufacturing related issues.
- Develop manufacturing processes by understanding product requirements : researching, designing, and testing manufacturing methods and equipment to enhance productivity and product quality.
- Improve manufacturing process capability and establish process control specifications.
- Create process validation master plan. Create equipment specification and software requirements.
- Participate new product development phase reviews and provide inputs representing manufacturing operations.
- Create or update production documentations and train production personnel and technicians on processes.
- Analyze and improve manufacturing process capability and product quality.
**Profil**
You hold a Master's degree in mechanics, biomedical, or related discipline, and have a minimum of 5 years of experience in the medical industry.
Knowledge and Skills:
- Knowledge and experience in Lean Manufacturing.
- Mechanical drawing reading and engineering level mathematics.
- Working knowledge of CAD and Minitab.
- Strong analytical and problem-solving skills.
- Ability to define, write, and perform test protocols for manufacturing process development.
- Ability to create detailed tooling and fixture drawing.
- Ability to create a basic strategy for new product process and equipment development and qualification. Set priority, plan, execute, and implement project from concept to completion independently.
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