Sr. Manufacturing Engineer
What you will be doing:
- Develops, evaluates and improves manufacturing processes at Insightec production, subcontractors and suppliers by studying product requirements, researching testing methods, and conferring with equipment vendors.
- Owning and leading Operations ECOs, Insightec internally and suppliers externally, From initiation thru all CCB steps, till release and implementation.
- Initiate and lead BOM cost reduction and process improvements projects improving Operations efficiency and gross margins.
- Led operations suppliers engineering, assuring suppliers ECOs implementation, SCR process and process improvements.
- Managing and maintaining Production BOM, drawing changes, critical components and EOL.
- Responsible for production training on NPI process, both at Insigthec production and suppliers.
- Leading Suppliers' engineering problem-solving and manufacturing engineering supervision to ensure product quality and specifications fulfillment.
- Member of the MRB team as the technical leader. Lead investigations, and corrective actions (including DOA).
- Design, improve and maintain production jigs and tooling.
- Collaboration with R&D, Service and QA teams on design improvements, DOAs investigations, product reliability, field team feedback, and quality improvement.
- Assures product quality by owning Incoming Inspection engineering instructions.
- Lead Manufacturing work instructions maintenance - new/ update/ Insightec format
- Lead Operations re-validation and production testers re-validation protocols and execution.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Provides manufacturing engineering information by answering questions and requests.
- Maintains professional and technical knowledge by attending educational workshops.
- Perform in-depth analysis of operational data to identify trends, patterns, and areas for improvements.
- Team guide in terms of priorities, technical questions, and more
- Member of the operations staff.
What you have:
- Sc. or higher degree – Mechanical Engineering.
- 8-10 years’ hands-on experience as manufacturing engineer, at list 5 at OEM company.
- Proven knowledge with complexed BOM managing and converting EBOM into PBOM.
- Excellent problem-solving skills.
- Experience with suppliers and subcontractors engineering support.
- Experience using CAD or CAM software.
- Takes initiative and takes charge without having to be told to act.
- Experience with data entry systems, quality control, dataset creating and maintenance
- Passion for Supply chain operations, improving work processes and continues improvement.
- Knowledge of relational databases (MS SQL etc.) and basic SQL or Python
- Must be organized, attentive to detail, and flexible with changing priorities
- Strong verbal and written communication skills in English.
- Excellent communication and collaboration abilities.
- Ability to work independently
- Knowledge of GMP, ISO, and FDA regulations specific to the medical device. Experience with FDA/CE supply chain audits.
Advantages:
- 3+ years’ experience with medical device.
- MRI environment experience
- ERP Priority experience
- Managerial experience
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