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 experienceLet us introduce ourselves
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company’s Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson’s Disease.
Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.
We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients. Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.
After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.