Take part of the complete Design architecture. - Instantly download in PDF format or share a custom link. Provide input into performance assessment of program team members. Contributing to risk management activities New Product Development Engineer Biomedical Engineers research and develop new medical technologies. Development Engineer (Medical Devices) Competitive salary & package. 7,494 Product Development Engineers Medical Devices jobs available on Indeed.com. 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 … 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. 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 … Don't miss your dream job. Experience in cardiovascular, product development in the medical device, analytical and biotechnology industries. 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. with 10 or more years of Epidemiology research experience, A well respected scientific leader with an established reputation at the national (minimally) or international (preferred) level with a record of publication in peer-reviewed journals, Possessing global experience within the Pharmaceutical or Medical Device industry and specifically within Phase III/IV, Convey a sophisticated understanding of, and the capacity to, interpret quantitative methods, Expertise in writing statistical methods sections of study proposals/requests or background epidemiologic material on specific diseases, conditions, or therapies, Experience working with large administrative or medical records databases as well as health authorities, Dynamic people leadership with direct or matrix management of other scientists is needed, Instrument improvements projects/activities e.g. Responsibilities: Keywords: R&D Engineer, EU MDR, new product design, TMV, medical device exp. Website: www.fleni.org.ar eMail: info@favaloro.edu.ar. Activities and Societies: Thesis: Development of an environmental management tool (a Hardware, Firmware and Software), designed for people with physical disabilities. Effectiveness will come from application of personal authority and expertise rather than hierarchical position, Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to non-active dental medical devices and orthopaedic medical devices, There is interface with and a need to influence all levels of the BSI organisation and at all levels of management in client and regulatory organisations, Work with technical team leaders as required, The position is office-based in Frankfurt. 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. 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 … Obtained a scholarship for good academic standing, award given by Favaloro University. Head of Medical Devices, Clinical Development Resume Examples & Samples 25%: Leadership and matrix management of all aspects of the Program Team activities, providing a strategic business perspective developing project strategy and modifying project … Planning, executing, managing cost, time, scope, Design Documents and quality, with the responsibility to complete the projects. Design verification and validation tests and write final reports. Download Medical Devices Resume Sample as Image file, In conjunction with Global Marketing and Business Manager, develop and support the relevant specific marketing to support business growth, Develop and evolve the relevant marketing package and tools in collaboration with the Global Operational Marketing Team. Medical Devices - Design & Development Engineer March 2011 to Current MBMed 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. Our client, a global medical device company, has engaged GForce Life Sciences to identify a Product Development Engineer … 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. Compliance with Quality Management Standard for medical devices and companies of the ISO 13485. ), 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. Mechanical design of optical devices. Apply to Product Development Engineer, Product Manager, New Product Development Manager and more! Solution of Customer Problems, and maintenance on-site. Our engineers are trained to understand all facets of product development and provide services throughout each phase of a product’s life cycle. Inspiring innovation at all levels, and in all aspects. 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. Hardware/Software Tech Development: Resume/Profile Examples. Ph.D. should be in a natural science or scientific discipline, At least 5 years of relevant experience with Medical Device development, In depth expertise and experience in the fields of Electronic Data Capture, Human Factors Studies, and/or eHealth, Knowledge and experience in big-data handling and digital health, as well as advanced analytics (e.g. It’s actually very simple. We are searching for engineers with "hands on" experience developing Class II electromechanical and Class III implantable medical devices. Brand, Product Marketing: Resume & Profile Examples. Filter by location to see Medical Device Engineer salaries in your area. 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. Allocates country budgets, based on local country-level communications requirements and is accountable for the achievements and budgets as agreed within the BP, Manages and develops a small team of communications professionals at country level, High energy and willingness to work in an environment where priorities and focus can change routinely, Analytical and problem-solving skills, including basic knowledge of financial and statistical information, Ability to put cohesive presentations together in PowerPoint, Be able to present confidently in large groups and in front of superiors, 3 – 5 years of relevant healthcare or industry experience, 5+ years of experience in leading complex software testing projects and other tester, 5+ years of web and test automation experience, 2+ years of experience in Agile software development and testing, 2+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development, Attention to maintaining excellent quality of work, Strong team-worker - effective relationship builder, Interprets and executes policies that affect work processes and personnel within the assigned organizational unit, Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit, Monitors compliance with company policies and procedures (e.g. Provide a key link to external Key Opinion Leaders in area(s) of focus, 15% Responsible for tracking progress against goals and composing monthly reports for senior line management and HGT/Shire Leadership team outlining key strategic events for program(s). Support a culture of high performance and trust. Promote and enforce compliance to guidelines. Create a Resume in Minutes with Professional Resume Templates, Global Product Manager Medical Devices Regulation, Complaint Analyst / Medical Devices Vigilance. plastic parts and generally good knowledge of and experience with engineering materials. A minimum of 1 to 3 years of product design or engineering experience in product development environment. Medical Device Sales Representative Resume Examples Medical Device Sales Representatives are in charge for selling medical products to clinics, hospitals, and other healthcare facilities. Development Engineer - Medical Devices. Equipment: Ventilators, high frequency Ventilators, Multiparameter Monitors, Capnographs, Anesthesia Machines, Infusion Pumps, Defibrillators, among others. Providing engineering guidance to product development teams in the design and development of Medical Devices Working with cross-functional teams to define system requirements that are appropriate, realizable, and testable. Principal New Product Development Engineer Resume Examples & Samples Bachelor’s degree and a minimum of 8 years of relevant experience is required Previous experience in highly regulated industry is required Orthopedic and/or Neurosurgical spine experience is desirable 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. These documents contain program milestones, strategic imperatives, and financial information regarding program(s), M.D. Network and Connectivity to Country Ecosystem Stakeholders. Responsibilities. Translate customer's product requirements into achievable product specifications and design features (Requirements Management). Creating 3D and 2D drawings for prototypes and manufacturing. 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. Create the Documentation to manufacture the new product (Procedures, work instructions, codes, drawings, labeling, and maintenance documentation). Because of the Commute Filter, your results are limited. Ability to communicate with affiliate in additional languages is an asset, Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes, The jobholder will be a member of the Orthopaedic & Dental Team reporting to the Certification Lead in Germany and work as a colleague with other members of the Medical Devices Business Stream. He is also hired for evaluating functionalities, and validating the prototype of medical devices. In our sample resume objective for Quality Engineer, we try to clinch the deal by disclosing the information that Aaron is a certified Quality Engineer with 9 year experience. 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. 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. Salary estimates are based on 249 salaries submitted anonymously to Glassdoor by Medical Device Engineer employees. 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. 2-year Fixed Term Contract. Meet international norms of medical devices like Electrical Safety IEC 60601-1, Electro Magnetic Compatibility IEC 60601-2, and Risk Analysis ISO 14971. Language C/C++, classes, inheritance, polymorphism, data structure, etc. Organize, plan, track and close out design problems, analyzing solutions with ingenuity and creativity, and making decisions. Medical Device standards), Coach and develop people; participate in recruitment of talent. Consultant, Product Development Engineer, MDR, Medical Devices. compliance with FDA, BSI, EEO regulations etc), Drive reengineering, standardization, harmonization of reporting solutions for all applications/systems in scope, Establish, govern and ensure adherence to cross-divisional/systems reporting standards, Establish and execute governance boards in partnership with teams and business groups, Follow the industry trends and address new business needs for Medical devices business unit, Provides excellent subject matter expertise and develops an environment, which fosters innovation, Defines and governs solutions inventory and leverage this inventory to ensure high reusability of the solutions, Ensure execution of projects within the team on time, on quality and costs, including management of vendors, Achieve the most efficient analytics Solutions (best in class) providing highest business value through effective management of resources, Partners with key stakeholders to define opportunities and identify Business Intelligence Solutions based on predefined criteria (e.g. Create and apply design and development standards and procedures. As such, it is not owned by us, and it is the user who retains ownership over such content. XYZ PRODUCT DESIGN COMPANY, Palo Alto, CA Product Design Engineer, June 2010-July 2015 Creating mechanical designs of medical and communication devices. A medical device quality engineer is responsible for identifying the requirements of and improving the quality of medical devices. MEDICAL DEVICES - DESIGN & DEVELOPMENT ENGINEER, Medical Devices - Design & Development Engineer. This also means that at one moment you will be working on the shaping the strategy for Flocare when the next day your focus will be on solving – as “second line expert” a practical issue that one of our clients is experiencing, Pioneering in new areas for growth and tapping in new stakeholders to ensure we stay ahead of competition, You are authentic in building your relationships, credible through your expertise proven ability to deliver on promise or even beyond, Provide expert advice to the TAs, R&D, and Business Units regarding Medical Devices, Electronic Data Capture, Human Factors Studies and eHealth, Provide consultative services for the development of a global clinical strategy and the operational conduct of global clinical development activities concerning Medical Devices, Electronic Data Capture, Human Factors Studies and eHealth, including for NMEs Phase IIII and for marketed products, with the aim to optimize product value (e.g. 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. This includes product development core team leadership of project / program lifecycle activities and general project and process initiatives, Lead cross-functional project team through the full program or project lifecycle, Lead product and process development efforts, and coordinate with core and extended team members from R&D, marketing, quality, regulatory, clinical, operations, supply chain, and other functions as required, Negotiate program expectations and ensure results are achieved, Maintain and forecast project budgets and resource allocations, Report program and portfolio strategy and status to the executive leadership team, Coach and mentor other Program and Project Managers, Play a key role in the establishment of strategy and standard practices for program management, Minimum 10 years engineering experience in medical device or diagnostic industry, Minimum 5 years in a Program Manager role, Strong understanding of product /project life cycle management and process development, Ability to think strategically at the program and portfolio level, Ability to effectively communicate, influence, and facilitate at the executive level, Understands and enforces Quality System requirements, Keeps abreast of trends, competitive activity and new technologies, Proven ability to manage program scope, schedule, risks, and budget and hold team accountable for results, Strong motivation and ability to self-start, Proven ability to work and build relationships cross functionally, Ability to coach/mentor Program/Project Managers, Development of technology strategy & roadmap to support our business plans in the industry, Overseeing the development and delivery of technology innovations for core & emerging technologies, including effective investment of development resources, Ensuring that the R&D team have the right skills, training & development plans to meet their objectives, Taking part in visits to potential customers alongside the Commercial team to secure strategic outcomes, and provide technical support and expertise to the customer, Responsibility for the Company’s IP and know-how asset base including the creation of a coherent patenting strategy, Educated to at least a Master’s degree level, or equivalent, in a technical subject relevant to the development of medical devices, A proven track record in Medical Device management and leading R&D project delivery, Expertise in innovation strategies, systems, programmes, and tools, Significant experience in Building Organisational Talent, and Coaching and Developing Self and Others, Familiarity with NPI frameworks and systems for Innovations, Customer Focus and the ability to proactively building collaborative relationships, Understanding of Intellectual Property legislation and the patent process, Ability to travel extensively internationally and to work flexible hours when necessary, Proficient in SQL Server or Oracle database, .NET technology or cluster/cloud architecture. Customer and solution -oriented. data analysis, forecasting, etc.) 2+ yrs in a similar role, preferably in medical device needle development. compliance with FDA, BSI, EEO regulations etc. 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). FDA, Novartis IGM framework), Manages, coaches and oversees internal and external resources in line with their targets, roles and responsibilities and the Novartis values & behaviors, Education: University degree or equivalent, Languages: English – fluent spoken and written. 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. The role also demands modifying/improving the existing medical devices to … Ability to present scientific and R&D activities appropriately to other functions, Strategic and strong influencing and shaping skills internally & externally, Comfortable with ambiguity and complexity, Ability to work effectively in a matrix environment and to lead multiple functions where required, Passion for innovation, value creation and ecosystem impact; Ability to keep on learning and extrapolate accurately from scientific medical expertise, Deep alignment with the J&J CredoMarketing, Write, Review and approve deliverables (e.g. Responsible for software, hardware and mechanical manufacturing projects from the perspective of planning, design for manufacturability, tooling, assembly, and production build. 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