Senior Manufacturing Engineer/Ingénieur industrialisation senior H/F

Montmorency, Val-d’Oise, France           ·            Full time

Senior Manufacturing Engineer/Ingénieur industrialisation senior H/F

Montmorency, Val-d’Oise, France

À propos de Balt

Notre objectif est de soigner 150 000 patients en 2026.

Notre histoire

Balt est un pionnier en pleine croissance dans un domaine exceptionnel. Depuis plus de 45 ans, Balt ouvre la voie – en collaborant avec des médecins et des institutions pour développer des dispositifs médicaux hauts de gamme. Nos produits sont utilisés par des médecins du monde entier. Nous avons 13 bureaux dans 11 pays – et ce n’est que le début.

Nous avons introduit l’un des premiers dispositifs d’intervention neurovasculaire en 1977 et offrons aujourd’hui le plus large portefeuille de dispositifs médicaux au monde pour les accidents vasculaires cérébraux. En tant que première plateforme neurovasculaire mondiale cherchant toujours à dépasser les frontières, nous apportons maintenant notre innovation à l’espace vasculaire périphérique.

Nous sommes fiers de notre mission, de nos employés et du travail incroyable que nous accomplissons ensemble pour permettre aux médecins de sauver des vies.

Pourquoi rejoindre Balt ?

• Travailler chez Balt, c’est donner un sens à son travail ! La fierté est un élément fort de notre identité.
• Nous sommes une équipe soudée, avec une mission, une vision et des valeurs fortes qui guident notre quotidien.
• La reconnaissance du travail, le respect et notre communauté multiculturelle sont des aspects essentiels de l’expérience des employés et contribuent à notre succès continu.
• Quel que soit le pays, nous prenons soin de vous.

Vous souhaitez faire partie de notre histoire ? N’hésitez pas et venez nous rejoindre.

About the opportunity

The Sr. Manufacturing Engineer (ME) is responsible for providing technical expertise, leadership, and planning to a large or several small technical projects. The Sr. ME will serve as a technical team leader and coach to junior engineers. The Sr. ME is accountable for the new manufacturing process and equipment development and validation, leading and executing Manufacturing process improvement and production sustaining projects. Normally he/she works independently and requires minimum supervision, receives general instructions on new assignments.

Main responsabilities

• Develop manufacturing processes by understanding product design requirements; researching, designing, and testing manufacturing methods and equipment to enhance productivity and product quality.
• Improve manufacturing process capability and establish process control specifications.
• Develop PFMEA and create process validation master plan. Create equipment specification and software requirements. Write IQ/OQ, OQ/PQ, and PPQ validation protocols and reports, conduct process, equipment, and software validations.
• Participate new product manufacturing process and equipment development and provide inputs representing manufacturing operations. Provide manufacturing decision-making information by calculating production, labor, and materials costs.
• Create or update production documentations, prepare and submit documentation change request (CRQ). Train production personnel, quality control, and technicians on processes, equipment, and documentation as needed.
• Stay current on technologies; utilize various tools (DMAIC, Gage R&R, Cp, Cpk, SPC, DOE, etc.) to analyze and improve manufacturing process capability and product quality.
• Interface with R&D, Quality Engineering, Purchasing, Logistics, Production, Regulatory, and external vendors to resolve manufacturing related issues.
• Manage project activities to achieve project and business objectives – initiate, plan, execute, monitor, control, and closeout projects. Provide status report to management on a timely basis.
• Perform any other duties assigned by manager.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to Quality Policy and all other documented quality processes and procedures.

Profile

Knowledge and Skills:

• Mechanical drawing reading and engineering level mathematics
• Knowledge and experience in Lean Manufacturing
• Working knowledge of CAD and Minitab
• Proficient in WORD, Excel, MS Project
• Design for Manufacturing (DFM) knowledge and experience applying DFM preferred.
• Strong analytical and problem-solving skills; ability to solve complex problems and implement solutions. Green belt Six Sigma certification is a plus.
• Hands on experience and knowledge of SPC, statistical techniques and methods.
• Ability to define, write, and perform DOE’s and test protocols for manufacturing process development.
• Ability to create detailed tooling and fixture drawing.
• Hands on experience and knowledge of manufacturing process and equipment development and qualification including software validation. Ability to write validation protocol and report, hands on experience and knowledge of IQ/OQ, OQ/PQ, and PPQ execution.
• Understanding of FDA medical device regulation, MDSAP regulations, ISO 13485, design controls, and process controls.
• Ability to create a basic strategy for new manufacturing process and equipment development and qualification. Set priority, plan, execute, and implement project(s) from concept to completion independently.
• Hands on aptitude.
• Demonstrated leadership capability in team settings.
• Strong verbal and written communications with ability to effectively communicate at multiple levels with internal and external organizations (i.e., R&D engineers, Regulatory, Marketing, Quality, Production Personnel, Purchasing, Material, Logistics, Vendors, etc.).
• Excellent written and oral communication
• Fluent in English and French

Educational background

• Master’s Degree in Mechanical, Biomedical, or similar engineering discipline with increasing responsibilities in Product Development, Manufacturing Engineering, or Process Engineering in the medical device field.
• Minimum 5 years working experience in Medical Device Industry

Please click here to apply.