משרות והצעות עבודה

מיקום: נתניה BioProtect Ltd היא חברת סטארטאפ רפואי בצמיחה, המפתחת פתרונות חדשניים להגנה על רקמות בריאות במהלך טיפולי הקרנות. הטכנולוגיה הייחודית שלנו מבוססת על בלון מתכלה, המסייע לשפר את תוצאות הטיפול ולהרחיב אפשרויות טיפוליות למטופלים. אנו מחפשים ראש/ת צוות ייצור Hands-on שיצטרף/תצטרף לצוות הייצור שלנו וייקח/תיקח חלק משמעותי בהובלת הפעילות והתרחבות הייצור. ________________________________________ תחומי אחריות • ניהול והובלת צוות עובדי ייצור/טכנאים בקו הייצור • תכנון והקצאת משאבים בהתאם לתוכנית הייצור • עמידה ביעדי ייצור תוך שמירה על איכות ועמידה בנהלים • ניהול שוטף של פעילות הקו, זיהוי תקלות ומתן פתרונות בזמן אמת • דיווח נתוני ייצור וביצועים, כולל עבודה במערכת ERP • הקפדה על עבודה בהתאם לנהלי החברה, GMP ודרישות חדר נקי • הדרכה, חניכה והסמכת עובדים, כולל הובלת התנסויות למועמדים • ייזום והובלת שיפורים בתהליכי ייצור • עבודה שוטפת מול ממשקים – ייצור, איכות (QA) ומו״פ (R&D) ןתמיכה בולידציות • ניהול מלאי חומרים בקו, כולל ספירות תקופתיות למה להצטרף אלינו? • הזדמנות לקחת חלק בחברה רפואית חדשנית עם השפעה אמיתית על חיי מטופלים • סביבת עבודה דינמית ומתפתחת • תפקיד משמעותי עם אפשרויות צמיחה והתפתחות

We are looking for a Hands -on QA Operations Team Lead to join our team and will play significant part in the production growth! Location: Netanya BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. Job Description: The QA Operations Team Lead is responsible for leading operation quality engineers’ team and ensuring compliance with applicable quality standards, and company procedures throughout production and operational activities. The role is responsible for supporting ongoing manufacturing activities while enabling efficient and compliant large-scale production expansion, ensuring operational readiness, timely execution of quality activities, and maintenance of product quality. The position requires close collaboration with Production, Engineering, Supply Chain, and other cross-functional teams to ensure that project milestones, manufacturing scale-up activities, and operational timelines are achieved effectively. In this position you will be asked to: • Lead the Quality Engineers team and provide professional guidance for: o Review and approval of validation activities, including Equipment Qualification (IQ/OQ/PQ), process validation, and validation documentation in compliance with quality requirements. o Execution of quality-related activities to ensure project timelines, and organizational objectives are achieved without compromising product quality. o Implementation of quality requirements for production processes, process improvements, validations, and operational changes. • Lead investigations related to production nonconformities, identify root causes, define corrective and preventive actions, and ensure timely closure and effectiveness verification. • Accountable for Production risk assessments to ensure risks are identified, evaluated, mitigated, and aligned with manufacturing changes and post-production information • Improve manufacturing work instructions to enhance clarity, compliance, efficiency, and manufacturability. • Support manufacturing scale-up activities, including transfer to increased production volumes, implementation of new processes, and expansion of operational capabilities while ensuring compliance with quality requirements. • Ensure effective training programs, qualification processes, and performance monitoring are established and maintained for QA operational personnel. • Monitor operational quality metrics and support initiatives to improve product quality, production yield, and process performance. • Collaborate with cross-functional teams to support continuous improvement initiatives. • Support internal and external audits, inspections, and regulatory activities related to manufacturing and QA Operations. A successful candidate will have the following qualifications: • Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline) • At least 5-6 years’ related experience as a quality engineer, in a similar role, in a medical device company • CQE – an advantage • Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QMSR, etc.) • Experience with statistical techniques, risk analysis, root cause analysis, Process validation etc. an advantage • Ability to work under pressure to meet schedules and deadlines within quality and regulatory standards • Strong verbal and written communication skills • Strong analytical skills • Strong problem-solving skills • Excellent English language skills (verbal and writing) • Experience with Class III implantable medical devices – an advantage • Experience with working in controlled environment (clean room) – an advantage BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We are looking for a QA Engineer to join our team! Location: Netanya BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: In this role, you will Oversee and assess the quality of manufacturing process In this position you will be asked to: • Support in-house quality activities in production. • Participate in non-conforming material processes, including investigations, MRB meetings, and implementation of corrective actions • Support Change control process (ECO), including development and documentation of manufacturing work instructions, training, and change assessments. • Data collection and analysis of trend (e.g., MRB, Yields). • Review Device History Records for accuracy and completeness for product release. • Support QC activities including in-coming, in-process and final inspection. • Define quality requirements for production and process improvements.

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: Production & Validation Engineer is responsible for supporting and improving manufacturing operations within a regulated medical device environment. This role ensures that production processes are efficient, compliant and capable of consistently delivering high-quality medical products. The Production Engineer works closely with cross-functional teams including Quality, R&D, Regulatory, Maintenance, and Supply Chain. In this position you will be asked to: 1. Manufacturing Process Support • Monitor daily production activities, troubleshoot issues, and provide timely technical support to maintain output and product quality. • Optimize manufacturing processes through root-cause analysis, cycle-time reduction, and waste elimination. • Develop and maintain work instructions and Test Instructions. • Collaborate closely with production and engineering teams Resolve process challenges within production facilities 2. Process Validation & Compliance – • Execute and document qualification/validation activities (IQ/OQ/PQ) per ISO 13485 and FDA 21 CFR 820 requirements. • Lead engineering investigation and Failure Analysis activities in Operation, on component, product or process level 3. Equipment & Tooling management • Validate new equipment, fixtures, and tooling. • Support preventive maintenance programs and collaborate with maintenance to ensure equipment uptime. • Perform equipment capability studies and implement improvements. • Lead engineering activity regarding design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes • Design new Jigs based on improvement recommendations. 4. Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support A successful candidate will have the following qualifications: • 5 years of experience in the medical devices industry - a must • Good understanding in mechanics- a must • Professional experience with Solidworks • Clean room work experience including process validation • Familiarity with FDA and ISO 13485 medical device regulations. – a must • Familiarity with Design for Manufacturability and Assembly (DFM / DFA) • Good technical, problem-solving, and hands-on skills - must • Education - BSc. Degree in Mechanical or Biotechnology Engineering. • Good analytical skills, self-starter with drive, focus, and initiative. • Language skills: Good English, both written and verbal • Personality: • Self-starter with drive, focus, and initiative • Good communication and interpersonal skills • An ability of technical leadership in matrix and changing environment. BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The opportunity: As a Clinical Team Member in BioProtect, you will be working with the clinical team, responsible for planning and execution of the company’s clinical targets. In this position you will be asked to: • Support the ongoing company clinical activities • Manage clinical data including database design, data entry and analysis • Support preparation of clinical documentation and IRB submissions as needed • Support the execution of the Post Market Clinical Follow Up (PMCF) and Post-Market Surveillance (PMS) data collection and analysis to ensure the safety and efficacy of our product. • Assist in complaint handling and vigilance activities. • Conduct literature searches and scientific articles review A successful candidate will have the following qualifications: • At least bachelor’s degree in biology, Biotechnology, or related fields • 1-3 Previous experience in clinical research with medical devices • GCP certified • Proficient in Excel • High level English proficiency, speaking and writing • A multitasker – can work with multiple deliverables, protocols and a wide range of people simultaneously. Have sense of accountability / urgency with ability to set priorities • Proactive attitude to solving problems / proposing solutions • Ability to work under pressure • Excellent self-management and interpersonal skills • Technical writing skills Advantages: • Familiar with FDA regulations • CRA certification

We are looking for a Quality Control Inspector to join our team! Location: Netanya BioProtect is an established Israeli startup in the medical device field, leading innovation in radiation protection. We develop and manufacture products suitable for a wide range of clinical applications in oncology and general surgery. The company’s flagship product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. What We Offer: In this role, you will be part of the quality control process for products that improve patients' quality of life. Excellent conditions for suitable candidates include competitive salary, advanced training fund from day one, meal card, Highway 6 access, and more! Responsibilities: • Supporting the production line with documentation tasks. • Checking the accuracy of production forms and identifying errors. • Entering production data into the database. • Responsibility for final product release. BioProtect is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

We are looking for a Cleanroom Production Technician to join our team! Location: Netanya BioProtect is an established Israeli startup in the medical device field, leading innovation in radiation protection. We develop and manufacture products suitable for a wide range of clinical applications in oncology and general surgery. The company’s flagship product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. What We Offer: In this role, you will participate in manufacturing products that improve patients' quality of life. Excellent conditions for suitable candidates include competitive salary, advanced training fund from day one, meal card, Highway 6 access, and more! Responsibilities: • Learning the expertise of various workstations, including assembly • Performing work processes in a cleanroom under written procedures. • Filling out production forms in Hebrew and English and adhering to strict standards • Teamwork—learning additional workstations beyond your primary specialization • Working with delicate tools—scalpel, microscope. BioProtect is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.