לוח משרות דרושים רפואה ופארמה לדוברי אנגלית

An innovative medical device start-up in the respiratory care industry. Inspira is developing the ART device, a cost-effective early extracorporeal respiratory support system with an intent to function as an Artificial Lung". The product is currently in a developmental stage. This s your Opportunity to join a fast-growing company, with the potential to disrupt a billion-dollar industry and touch millions of lives by developing a unique medical device solution. For more information, please visit the company website: https://inspira-technologies.com/ We are now looking for a Medical Device Senior V&V, experienced in managing, planning, and executing the product V&V process, and wants to join our inspiration! Duties & Responsibilities: Establishment company Verification and Validation infrastructure:
* Define V&V Strategy for product development throughout product lifecycle
* Define V&V testing methodologies and coverage.
* Plan and establish the companys V&V test lab and test equipments
* Define and write the V&V testing working procedures.
* Work close with R&D, QA, regulation and take part in product development Performing and managing the V&V tests:
* Write V&V Protocols and reports.
* Define and execute V&V tests for system and subsystem levels.
* Managing and analyze tests data.
* define and manage the execution of Safety validation activities at 3rd parties for compliance with applicable standards (EMC, Safety)

REPORTS TO: CEO

The General Manager (GM) of the companys Israel site is responsible to lead all facets of the
site team and operations, in collaboration with the companys US management.

RESPONSIBILITIES:
Direct and lead the commercial, clinical, regulatory, R&D and G&A activities of the
operations in Israel.
Manage all profit and loss activities associated with Israeli operations
o Manage the budget while pursuing company strategy and goals
o Manage grant support activities and reporting
o Ensure that financial statements and tax filings are completed and filed
Contribute to company strategy, planning and execution as part of the companys
executive team
Manage the interface between the Israeli and US sites
Direct and lead commercialization and development in the European Union (EU) and, if appropriate, through partners in other countries
Support the FDA filing,

At least 5 years as Senior quality engineer or quality manager in medical devices industry
Experience with ISO 13485: 2016 Quality system implementation and maintenance (MDR an advantage).
Good knowledge in EU Regulatory affairs requirements EU MDD, MDR and US-FDA
Quality auditor qualifications a (lead auditor certification, an advantage)
Experience with quality / QC aspects in clean room environment

Leadership & Management of multiple R&D teams (20+ employees) in a fast- growing multidisciplinary deep- tech medical device company
Establish overall R&D strategy, focusing on existing and future development to ensure timely new product introduction
Define R&D goals and plans for current and future products / features, including contents, resources, schedule, and budget
Directing and supervising the R&D teams throughout the entire product development lifecycle and design control stages- requirements, design, V&V, transfer to production, maintenance, etc.
Providing technical leadership in the core technology of the company
Review of future technologies and features to improve the product
Part of the management team of the company - contribute to the company long-term planning of goals, budget, resources, organizational structure and procedures, etc.

Lead Global clinical strategic planning activities and translate strategic decisions into actionable plans.
Provide oversight of site selection, initial contract negotiations and patient recruitment programs.
Provide oversight of CRO selection and budget to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
Collaborate cross-functionally with internal departments such as Marketing, Regulatory Affairs, R&D and Quality to ensure clinical program compliance.
Provide input into clinical protocol design and associated budgets.
Oversight progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress, also reviewing and acting on trending reports.
Achieve enrollment rates consistent with company goals.

Design and development of invasive medical products, sub-assemblies, components and manufacturing process according to clinical specifications and regulatory requirements. From concept to production line implementation
Prepare detailed drawings, specifications and work-instructions
Perform as a subject matter expert in the fields of engineering calculation, material selection, manufacturing technologies, CAD and testing designs
Generate technical reports and regulatory documents.
Verify the functionality of products design by developing test methodology and specifications to ensure that products design meet applicable performance requirements
Design, execute, analyze & document tests: verification in-lab jigs and Ex-vivo validations
Design and implement device improvements & modifications
Interfaces with outside vendors for component selection, manufacturing

We are looking for a Project Manager, with experience in medical devices, to lead our project management efforts
Lead the project management efforts as part of R&D, including work plans and execution from definitions and requirements through design, implementation, integration and V&V to obtain regulatory clearance and reach product release.
Ownership of system level project work plans, execution and control, working with the various functions and managers.
Collaboration with Q&R to implement relevant processes and support for clinical and regulatory efforts.
Hands on leadership of various operational efforts.
Work with and monitor external partners and subcontractors.
Lead transfer to production efforts and field monitoring activities.
Reporting to: GM of the site in Israel