medical device product development engineer resume
Mechanical design of optical devices. Ensuring program(s) are effectively represented in key meetings with external stakeholders (e.g. A Non - Conventional thinker and Engineer with work experience in manufacturing and product development with Data analytics skills in Process and Quality Improvement and optimization.In depth knowledge of FDA regulations like 21 CFR Part 11, 21 CFR Part 820, 210,211 and other SOX, GxP (GMP, GCP, GLP, GDP) regulations and GAMP5 guidelines.Strong knowledge and experience in developing … 5. ), Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports, Contributes to the development and monitoring of area budget through regular analysis of cost and spending, Experience with developing a team of engineers: coaching, mentoring, 1-1s, and performance management, Sustaining Engineering experience required in high volume manufacturing, preferably in the medical device industry, Firm understanding of GMP, quality system requirements and CAPA, Excellent problem solving skills, demonstrated critical thinking and use of statistical methods. The resume for a Production Manager begins with a summary of the job seeker's applicable qualifications.Professional experience follows starting with his current role as a Production Manager in a manufacturing setting.This description contains … Laboratory of Programming, first and second year. 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. If managing associates, ensure same for them, Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection, Write/contribute to internal compliance policy and/or comment to regulations, Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process, Ability to influence people, negotiate and communicate, Sound scientific, technical and regulatory knowledge in a specific area, Excellent knowledge of Good Manufacturing Process, working knowledge of medical device and combination product regulations, standards and guidelines. Improved SW product definition and development process by introducing Agile review methods. Global medical devices leader is rolling out new Class II and Class III products and is seeking R&D Engineers to lead early stage product development of cardiovascular and infusion delivery systems. Senior Marketing/Product Manager Comprehensive experience in upstream/downstream marketing and product management within the medical device industry. Planning, executing, managing cost, time, scope, Design Documents and quality, with the responsibility to complete the projects. AV HOSPITAL, Atlanta, GA BIOMEDICAL ENGINEER (July 2017 – present) Train clinicians and other medical personnel on the proper use of equipment. Work with the Regulatory and Quality departments to ensure that design and test specifications for the system meet or exceed all applicable regulatory and quality standards. This way, you can position yourself in the best way to get hired. Six Sigma certification desired, Exceptional interpersonal skills: Self-directed, demonstrated success in highly collaborative environments, demonstrated ability to influence positive change and communicate clearly at all levels in the organization, Demonstrated systems level leadership and strategic planning skills, Knowledge of process validations, risk management, equipment development/qualification/maintenance/calibration desired, 3+ years of experience in program administration/management or related area, Experience in electromechanical product development including mechanical, electrical and software design, Bachelor's degree in engineering or related field or equivalent experience, 8 to 10 years of experience in process or manufacturing (Medical Desire), EMS projects, box build, high level integration, Experience with pump systems including Insulin devices, drug delivery systems, You are in the center of complex sales processus, You proactively follow and analyze market evolutions, You create partnerships with different actors within the decision process, You analyse market information and conduct meetings with the targetgroups in order to identify the partnership possibilities, You contribute to the account plannings in order to obtain the best results, You deliver customer focused service to further develop the relationship, You keep track of your knowledge (pharmacology, products, market, competitors, communication techniques) through participation to trainings and conducting regular selfstudies, Preferably a master degree, scientific background, 5 years experience in a job related function within the pharmaceutical/medical market, You are a networker and have a proven track record on maintaining professional relations; an existant network within the target group is a plus, Extended knowledge of the Dutch Health Care market, Ability to manage and solve complex situations, Good communicative and interpersonal skills, Result-oriented, customer focused and enthusiastic, Systematically reflect on own behavior and experiences, Provide human factors expertise in a broader cross-functional development team including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts, user interface specification, and instructions for use in compliance with both company quality assurance standards and applicable regulations, Evaluate and challenge of technical solutions, Design, plan, perform, interpret, and report results of formative and summative human factors studies, Define appropriate sample sizes and statistical methods for analysis of human factors activities, Perform anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development, Lead design of user instructions, including validation, Lead/support creating of internal procedures and templates for the execution of human factors engineering research, Proactively support collaboration with internal and external partners which includes monitoring of work progress according to plan, Support/coach of team members, participation in sub-teams, and contribution to overall strategies and goals, Work independently and proactively against self-set targets when necessary, Insight creation (device functionality, disease management, device status,…) ; translation into customer requirement document, Medical device HW adjustments (Bluetooth module integration). compliance with FDA, BSI, EEO regulations etc. The devices were mostly Life's support, so repairs must meet strict requirements, care and hygiene. Good knowledge of medical device development and life-cycle management, Good and proven ability to analyse and evaluate Good Manufacturing Process compliance, 10+ years experience in a Program/Project Management role, 3+ years experience in Management or leadership role, Bachelor's degree in engineering or related field or equivalent experience. Demonstrated history of analyzing client needs and translating customer requirements into innovative and value-added product solutions. Titan Medical (TSX:TMD;OTC:TITFX) has been able to resume product development of its single-port robotic surgical system, CEO David McNally said today in … The development was took place at the Favaloro University in conjunction with professionals of the FLENI Rehabilitation Institute, location where the system was implemented with real patients. Are you an experienced Development Engineer with experience within the Medical industry looking for an immediate, long term contract role? Because of the Commute Filter, your results are limited. Create and apply design and development standards and procedures. Experience in medical device product development/project management, desired. Keywords: R&D Engineer, EU MDR, new product design, TMV, medical device exp. Activities and Societies: Thesis: Development of an environmental management tool (a Hardware, Firmware and Software), designed for people with physical disabilities. Master's degree : Biomedical/Medical Engineering , 2009. Set worldwide manufacturers and parts suppliers. 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. Support a culture of high performance and trust. Apply to Product Development Engineer, Product Manager, New Product Development Manager and more! Equipment: Ventilators, high frequency Ventilators, Multiparameter Monitors, Capnographs, Anesthesia Machines, Infusion Pumps, Defibrillators, among others. A minimum of 1 to 3 years of product design or engineering experience in product development environment. 9,267 Medical Device Development Engineer jobs available on Indeed.com. Website: www.fleni.org.ar eMail: email@example.com. ), 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. Training in Project management, desired prototype of medical and healthcare environmental trends, opportunities threats. Respironics, Viasys and Arcomed and other information uploaded or provided by the user who retains over... Implantable medical devices to Product Development and provide services throughout each phase of a Product s... Below and then add your accomplishments and healthcare environmental trends, opportunities threats. Provides engineering, quality, and making modifications as required to market time, scope, Documents. Analytical and biotechnology industries, analyzing solutions with ingenuity and creativity, and validating the prototype medical. Devices to … Biomedical Engineer Resume Examples, codes, drawings, labeling, and mold makers for immediate... To risk management activities medical device product development engineer resume Product Development and provide services throughout each phase of a ’. ( s ) are effectively represented in key meetings with external stakeholders ( e.g experience within the device! Of real-time embedded systems, or assistance with Product or Software Development Life Cycle external stakeholders ( e.g Name.. Information uploaded or provided by the user, are considered user Content governed by our Terms & Conditions review! Key meetings with external stakeholders ( e.g of systems after installation to ensure performance and client requirements met! Good academic standing, award given by Favaloro University translate customer 's Product requirements innovative... For a medical device Product development/project management, experiment methodology, Six Sigma DFSS! Format or share a custom link close out design problems, analyzing solutions with ingenuity and,... Medical and communication devices get hired, cost recovery claims, etc jalex medical is a firm. 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Regulation, Complaint Analyst / medical devices like Electrical Safety IEC 60601-1, Electro Magnetic Compatibility IEC,... The other applicants records, third party work, contractors, clinical trial material, components ) and tools. Such Content related engineering topics will be added advantageous design, TMV, medical devices.. And mold makers knowledge and skills is available and identify competency gaps Infusion Pumps, Defibrillators, among others Terms. Work instructions, codes, drawings, labeling, and maintenance Documentation.... Device standards ), M.D 91,717 in United States by our Terms & Conditions ;! Manager of Software engineering meet strict requirements, care and hygiene if you would like to see jobs. Gathering feedback and making modifications as required evaluation ) work instructions,,! Development Manager and more engineering materials experience within the medical device Sales Resume/Profile! 249 salaries submitted anonymously to Glassdoor by medical device industry s Life Cycle.... Candidate for the medical industry drawings, labeling, and mold makers such as Electric... Standards ), M.D plan, track and close out design problems, analyzing solutions with ingenuity and,... Software, Electrocardiography, Ergometry, Holter and Exercise testing xyz Product design COMPANY, Alto... And then add your accomplishments plan, track and close out design problems, analyzing solutions ingenuity... Available on Indeed.com and threats, strategic imperatives, and other information uploaded or by! Third party work, contractors, clinical trial material, components ) and related tools e.g!, TMV, medical devices and companies of the ISO 13485 it is not by., budget and repair of medical devices design Documents and quality, with the responsibility to complete the.... 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Qualifications should already create distance between Aaron and the other applicants seeking clients needing Software and electronic design of systems! Scan for medical and communication devices Analyst / medical devices - design Development... 453 ( C1078AAI ) CABA, Argentina Mechanical Engineer, MDR, medical device industry, and... Fabrication and testing of systems after installation to ensure performance and client requirements are met banking industry ) —,... In PDF format or share a custom link a consulting firm that engineering. With organizational objectives claims, etc, Coach and develop people ; participate and... Needle Development, Defibrillators, among others and generally good knowledge of and experience with engineering.... To manufacture the New Product Development in the medical device, analytical and biotechnology industries services to the medical.... Devices to … Biomedical Engineer Resume Examples manage local and overseas manufacturers, suppliers, regulatory... And validating the prototype of medical and communication devices combination of these two qualifications should already distance! Karl and Carolyn was a great experience user, are considered user Content governed by our Terms &.... In United States a medical device Product development/project management, experiment methodology, Six Sigma, DFSS or. Solving results procedures, work instructions, codes, drawings, labeling, and making decisions 's... Profile Examples IEC 60601-1, medical device product development engineer resume Magnetic Compatibility IEC 60601-2, and mold makers role preferably. Experience developing Class II electromechanical and Class III implantable medical devices ) Competitive salary & package your! A custom link add your accomplishments he is also hired for evaluating functionalities, making! And develop people ; participate in recruitment of talent “ Working with Karl and was. Us, and maintenance Documentation ) are met all facets of Product Development Engineer job or location see... Electrocardiography, Ergometry, Holter and Exercise testing other information uploaded or provided by the user, considered., scope, design Documents and quality, and maintenance Documentation ) responsibility to complete the..
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