Onera is hiring Manufacturing Engineer, who will be responsible for all technical activities related to product manufacturing, both internally and at external suppliers and contract manufacturers.
Onera is hiring Manufacturing Engineer, who will be responsible for all technical activities related to product manufacturing, both internally and at external suppliers and contract manufacturers. Activities typically include tooling and fixture design, manufacturing process development and validation, design transfer into manufacturing, troubleshooting and sustaining engineering, and continuous improvement.
Onera is a spin-off company of IMEC andamp; Holst Centre, the world leading research center in nanoelectronics and digital technology (). Oneras ambition is to bring innovative medical devices to the market that will help improve the health and quality of life of patients around the world. Onera is currently developing its first product for the sleep market.
You will be part of a multidisciplinary, energetic, young, and internationally minded start-up team. You will have the different responsibilities listed below:Develop, implement, monitor, and improve manufacturing processes using best practice tools such as Failure Modes and Effects Analysis (FMEA), Gage Repeatability and Reproducibility (GRandamp;R), Design of Experiments (DOE), Verification and Validation (Vandamp;V), Statistical Process Control (SPC), and other data driven techniques Create, update, and maintain production documentation, including but not limited to CAD models, part drawings, assembly drawings, bill of materials, travelers/routers, work instructions, test methods, protocols, and reports Design production fixtures and tooling and specify production equipment, ensuring they meet safety, quality, capacity, and cost requirements Train and certify manufacturing personnel Validate manufacturing processes, including Installation Qualification (IQ), Operational Qualifica-tion (OQ), and Performance Qualification (PQ) activities Lead production transfer activities to contract manufacturers or other internal production centers As member of the material board responsible for resolving non-conformities in the receiving, in-line and final acceptance process (responsibility) Ensure manufacturing lines are compliant with FDA QSR and ISO 13485 regulations, any other general safety regulations Work closely with vendors and subcontractors to resolve production issues and ensure purchased materials and components meet specifications Conduct preventive maintenance on applicable production tools, fixtures, and equipment Establish, monitor, and report key performance indicators such process yield, Takt time, total cost, total cycle time, etc. Apply Lean Manufacturing principles to continuously improve production processes Support new product development by providing Design for Manufacturability (DFM) inputs to new product designs, establishing pilot scale manufacturing for low-volume prototype builds, and building product for design verification and design validation tests.
Your ProfileBachelor/ Masters degree in an engineering field 5+ years of experience in engineering, medical device manufacturing experience preferred Tooling and fixture design experience Process validation experience Working knowledge of GMPs, FDA QSR, and ISO 13485 regulations Geometric Dimensioning and Tolerancing (GDandamp;T) and SolidWorks experience Strong project management experience and skills Demonstrated problem solving skills and methodology Ability to work with little day-to-day direction; must be self-directed and willing to take initiative Must be able to work and communicate effectively across all levels and functions of the organization Lean Manufacturing or similar continuous improvement/ World Class Manufacturing methodology required High level of attention to detail Willingness to travel (occasionally) Legally authorized to work in the Netherlands (already possessing a visa/EU residence permit) Excellent communication skills in English (written and spoken)
If you are interested, please :(Please contact us using the "Apply for this Job Posting" box below)
Torenallee 42-54, 5617 BD (Strijp-S), Eindhoven, Netherlands.
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