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Smart Shooter is looking for an experienced Mechanical Engineer with strong capabilities in mechanical and opto-mechanical design for leading development projects, product design, and working in a multi-program, highly multidisciplinary environment. The role includes end-to-end development of mechanical systems, from concept and detailed design through manufacturing, testing, and integration, supporting advanced and complex products in dynamic engineering environments. ?About Smart Shooter Smart Shooter is a world-class designer, developer, and manufacturer of innovative Fire Control Systems that significantly increase the accuracy and lethality of small arms. With a rich record in designing unique solutions for the warfighter, Smart-Shooter’s technology enhances mission effectiveness through the ability to accurately engage and eliminate ground, aerial, static or moving targets during day and night operations. Responsibilities
* Design and development of mechanical systems, including mechanisms, opto-mechanics, and miniaturized electronic packaging
* Lead product development from concept through delivery (detailed design, manufacturing, testing, and customer support)
* Collaborate closely with cross-functional teams including electronics, software, systems, and manufacturing
* Work with suppliers and subcontractors

We are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are seeking a talented QA /RA Engineer to join our quality and regulatory team, playing a dual role that ensures our products meet the highest quality standards while navigating complex global regulatory requirements.
SCOPE & RESPONSIBILITIES
Quality Assurance Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. Manage DCOs in the PLM system : write and update QA procedures to ensure compliance with quality standards and regulatory requirements. Manage NCR and CAPA processes: lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. Manage QA production activities: provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. Ensure timely resolution of quality issues: promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EU MDR, and MDSAP requirements. Supplier Quality Management: manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.
Regulatory Affairs Prepare, coordinate, track, and follow up on submissions for medical devices across various international markets. Prepare and manage EU MDR technical documentation submissions. Oversee CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall. Participate in regulatory inspections and audits. Prepare regulatory assessments for design changes. Develop labeling according to applicable regulatory requirements. Evaluate and communicate regulatory impact of ECOs and design changes across QA and RA domains.