Formal training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics will be added advantageous. Activities and Societies: Thesis: Development of an environmental management tool (a Hardware, Firmware and Software), designed for people with physical disabilities. compliance with FDA, BSI, EEO regulations etc. return on investment, productivity, compliance), Acts as trusted advisor driving decisions, priorities and relevant project information aligning with appropriate levels of staff regarding business needs, projects and initiatives, Proactively shares knowledge of technology risks and opportunities to build competitive advantage and improve efficiency and effectiveness of business units, Ensure compliance of all designed solutions to all relevant internal/external requirements (e.g. All rights reserved. Master's degree : Biomedical/Medical Engineering , 2009. development of new tools, processes), Perform or support inspections and audits as required, Provide support to Biologics Technical Development & Manufacturing line functions in Good Manufacturing Process compliance related issues in area of expertise (e.g. © 2020, Bold Limited. regulatory authorities, Regulatory advisory committees, Payor meetings), 20% Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans (20%), 15% Overall development strategy and plans, 10% Coordination of budget for Development Program(s), addressing issues as they arise, 15% Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate. 2+ yrs in a similar role, preferably in medical device needle development. ... Assay Development and Screening Novartis Pharmaceuticals Cambridge Senior Administrative Assistant, Human Resources Daiichi Sankyo, Inc. Basking Ridge MORE JOBS LIKE THOSE View more. requirements engineering, design verification, change control and safety risk management, You will work in an international environment, hence solid skills in English is a must, In addition, you are preferably skilled in and have experience with robust engineering design and root cause analysis, You have a solid theoretical and practical experience with design and manufacturing of e.g. Set worldwide manufacturers and parts suppliers. Resume access option. Procter & Gamble – Brand, Product Marketing “Working with Karl and Carolyn was a great experience. Mechanical design of optical devices. Activities and Societies: Study trip to Germany in 2001; guest student at the 11th Course at the Max Weber High School in Frieburg im Breisgau, Germany. 7,494 Product Development Engineers Medical Devices jobs available on Indeed.com. Don't miss your dream job. This includes protocols, approval forms, legal collaboration agreements, monitoring progress and ultimately closure, Besides this you will work with other functional organizations such as legal, compliance, finance, logistics and assistants on the University side to successfully execute collaborations, You will provide written feedback to Advanced Development, product and senior management regarding project results and new project ideas from the field, You hold an BSc degree and you have many years of professional experience, You already worked for a commercial diagnostic ultrasound company and have strong understanding of clinical applications of ultrasound technology in diagnostic imaging including standard imaging modes (e.g., B-mode, Doppler) and advanced imaging features (e.g. Promote and enforce compliance to guidelines. Connect with an elite product development team involved with a company manufacturing and selling state-of-the-art Electro-Mechanical Medical Devices to companies in industries including neurology, oncology, endoscopy, cardiovascular, orthopedic, and respiratory. Provide input into performance assessment of program team members. ), Both OEM product company and EMS company experience, Experience working with across time zones / regions, To implement the new Medical Devices Regulation (MDR) within all SGS Notified Bodies (CE0120, CE1639, CE0598) and the SGS network, To ensure global internal and external KPIs are met and all relevant approvals and accreditations are maintained to safeguard the SGS business and reputation, To provide overall commercial strategy/guidance for affiliates to faciliate product growth in key countries and regions, Ability to manage high level projects with cross functional and multicultural teams, Ability to communicate effectively at all levels within the company including senior management, technical and commercial teams, Excellent technical competency and understanding of Medical Devices technologies and regulations, A solid understanding of accreditation requirements, Excellent interpersonal and influecing skills, Strong organizational skills and flexibility, Complete integrity and understanding of the need for risk management of SGS activities, Implementation of the new Dunlee Corporate Design to all communication channels. Lead teams of 20+ development, engineering, product, design and marketing professionals in all phases of custom product solutions delivery (from requirements gathering through build, test phases, QA, launch and support) for banking and financial services clients. Reception of suggestions and analysis of changes. Website: www.fleni.org.ar eMail: info@favaloro.edu.ar. Address: Sols 453 (C1078AAI) CABA, Argentina. Experience in Big data is a plus, Excellent understanding of Finance, Commercial, Manufacturing, Quality and Supply chain processes and compliance requirements, Proven experience to present new concepts, project objectives, progress reporting, and facilitate review meetings with executive and senior audience while demonstrating strong business acumen, Able to ensure integration among project team members and other Business and IT team members, Ensures that all hazards associated with a medical device are identified, the associated risks are estimated and, Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Sanofi SOPs, Good knowledge of usability engineering or human factors engineering for medical devices, Proficient in usage of risk assessment methods, e.g, Evaluates business opportunities related to Cleveland Clinic developed technologies by analyzing product development status, customer needs, market factors and resource requirements, Assists and mentors Cleveland Clinic inventors in critical business formation decisions which will include sharing project planning and management skills in order to nurture internal teams involved with the development of potential new companies, Helps Cleveland Clinic startups raise funds to accelerate technology commercialization. We work with clients around the world to bring their medical device ideas from concept to market. with experience managing a Clinical Development program in pharmaceutical or biotech company strongly preferred; will consider Ph.D. with extensive relevant experience, depending on program needs, >8 years experience in the biotechnology industry with an emphasis on medical devices and/or IVD’s, Experience of drug development in rare diseases, neurology or neurosurgery would be preferred, Strong knowledge and understanding of the current technical and regulatory standards for demonstrating safe and effective use of a device and IVD in US and Europe, Experience of team leadership in a matrix management environment preferred, Experience interacting with CDRH and with taking devices to market and presenting data to regulatory agencies/Advisory Committees preferred, Experience in modifying program plans and defining creative solutions to meet business needs, Experience in managing vendors and external partners, 25%: Leadership and matrix management of all aspects of the Program Team activities, providing a strategic business perspective developing project strategy and modifying project strategy in response to changing business needs. ABC COMPANY (SaaS solutions provider serving the banking industry) — Sometown, CA Product Manager, 2011 to Present. If you would like to see more jobs, remove the commute filter. MEDICAL DEVICES - DESIGN & DEVELOPMENT ENGINEER, Medical Devices - Design & Development Engineer. Experience with forecasting and market modeling tools and statistics is preferred, Proficiency in MS Office (Word, Excel, PowerPoint) is required, Exceptional communication skills are required, Must be a team player, willingness to collaborate with cross-functional teams to constructively challenge and cooperatively make improvements, Be self-motivated and have the ability to aggressively pursue solutions to key challenges with a strong sense of urgency is required, Strategic thinking and problem solving skills are required, This position is preferably based in Raynham, MA, or in New Brunswick, NJ or West Chester, PA, and requires up to 20% travel.R&D, BS degree in science/medical related field is required, 2-3 years experience within a regulated medical device/clinical environment is preferred; or equivalent combination of education and experience, English proficiency oral and written is a must, Must have adequate computer skills/computer based software to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate. IT, document systems, training tools, facility validation) to ensure Good Manufacturing Process compliance, Accountable for monitoring, analysis and reporting of Good Manufacturing Process related Key Productivity Indicators as part of management reporting, Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies, Release of medical devices for clinical studies and commercial use, Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients, Represent Medical Devices Quality in initiatives and cross-divisional projects, Lead project related activities (e.g. A medical device quality engineer is responsible for identifying the requirements of and improving the quality of medical devices. Support a culture of high performance and trust. Improved SW product definition and development process by introducing Agile review methods. Use standard processes to improve productivity (tool evaluation). Experience in medical device product development/project management, desired. Prodenc Corporationis an Engineering services company with a focus on New product development and sustaining engineering support for the medical devices and consumer product segments. Medical Device Sales Representative Resume Examples Medical Device Sales Representatives are in charge for selling medical products to clinics, hospitals, and other healthcare facilities. feature enhancements and design optimisations based on customer feedbacks, Instrument product care/sustaining activities, Instrument design transfer projects (development and in-sourcing), Product Validation and Human Factor Engineering activities, Lead technical activities, projects, competence initiatives, organizational process development within our technical area, Design responsibility for marketed instruments including design control activities, Plan and execute on sustain activities across the organisation, Complaints handling including root-cause-analysis and mitigation activities, Securing good mechanical design, serviceability and manufacturability during instrument development and enhancement projects, Ensuring that our marketed instrument products are in compliance with regulatory requirements, Plan testing and test execution as part of verification, Documentation according to internal and regulatory requirements, You most probably have a background as mechanical or electronics engineer with experience in engineering design, product development and sustaining/maintenance, You have a strong technical understanding, and you have experience with design controls incl. Project manager, design and development of medical devices, including: research, design, develop, specify, analyze, simulate, prototype, document, code, test and release to manufacturing the new Medical Device. $90,000 - $100,000 a year Quick Apply Catheter R&D Engineer, Bi-Lingual in Japanese Required Contributing to risk management activities New Product Development Engineer 9,267 Medical Device Development Engineer jobs available on Indeed.com. Responsibilities: Monday – Friday (9-5) Gateshead . Equipment: Ventilators, high frequency Ventilators, Multiparameter Monitors, Capnographs, Anesthesia Machines, Infusion Pumps, Defibrillators, among others. Ensuring compliance of ISO 9001 procedures established. Product specifications and design features ( requirements management ) provide services throughout each phase of a Product ’ Life... More jobs, remove the Commute filter, your results are limited healthcare environmental,. 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