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  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
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Recent Remote Wireless Monitoring Inquiries

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Internal & Supplier Audits In Medical Device Industry

Project title: to assess the global market for internal audits and supplier audits in the medical device industry. Description/need: we are currently conducting a study to understand the global market for internal and supplier audits in the medical devices sector. For this, we are trying to speak with respondents who are working with medical device manufacturing companies in the auditing team. Number of experts: 4 - 5 timeframe: from 26th may to 30th june geography: usa, uk, germany, china, japan and india companies zintro can try to reach out to: medtronic, siemens, fresenius medical care, cardinal health, etc. (or any other companies that provides products related to medical devices) companies zintro should not reach out to: general electric, johnson and johnson expert job title(s): respondents that are at the following designations or higher - • audit manager • internal auditor • quality control manager / analyst • safety manager • sustainability consultant / team screening questions: 1. How often are internal and supplier audits (customized audits) undertaken in your industry/company? 2. What functional themes are these audits related to (for example, quality, sustainability, cyber security, good manufacturing practices (gmp), etc.)? 3. Are these audits usually conducted by an internal team or by an external auditing company? 4. What are the key challenges that customer face while conducting internal and supplier audits? 5. Based on your experience, which functional theme will witness the highest growth for internal and supplier audits and why? 6. What are the key selection criteria that your company considers while selecting a customized audit service provider? 7. Do companies have any unmet needs or expectations from the customized audit service providers?

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    Ken |President

    I worked for the global leaders in the medical device industry. Becton Dickinson, Roche Diagnostics...

    2 Hours Later
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    Santosh |Zintro Expert

    I have performed internal and supplier audits to ISO 9001 and ISO *****. Performed audits in the USA...

    2.1 Hours Later
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    Duane |Sales Representative

    I have spent my entire career in sales of Healthcare Products. If this qualifies me for this line o...

    2.5 Hours Later
+15 Other Responses
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Combination Medical Devices

We are using a new api as an active ingredient in a coating formulation to be applied to a wide variety of medical devices. The api elutes out slowly over time. Looking to find an expert with tox and regulatory knowledge on combination medical devices (device/drug) spanning many different fields of use: dermatology, vascular access, respiratory, orthopedic and others.

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    Courtland |CEO

    We have excellent knowledge in pharma and device. Please let us know if we can help you. We only h...

    2.2 Hours Later
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    B |abc

    Dear Inquirer: am a professional with more than 10 years of experience in biotechnology and life s...

    2.5 Hours Later
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    John |Director of anesthesia

    Hi As an anesthesiologist I started a pharmacetical company to develop a safer opioid that minimize...

    2.7 Hours Later
+16 Other Responses
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Medical Device Manufacturing Landscape

Have a potential client that we may do research for. Am trying to get a feel for whether or not we can actually find them the right respondent types. They are looking to speak with key decision makers of medical device manufacturers, specifically looking to speak to them about the following: - identifying pain points, fears, uncertainties, and potential points of confusion that they can address through marketing communications - establishing the audiences that have the most interest in and need for the client's services - what motivates them, where do they get information, etc. - questions/concerns that manufacturers have about entering the chinese market and work with the cfda - general unmet needs or medical device manufacturers as it pertains to better grasping standards set for class ii or iii devices by the cfda, fda, or ema. If there is anyone that feels they might be the right person to speak with for this study, or know what title(s) we should be targeting at the manufacturers, please send me a message. Targeting key decision makers that actually work for a medical device manufacturer thank you!!

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    William |VP, Regulatory, Clinical and Compliance

    See attached two documents, Bill J...

    1 Hour Later
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    Robert |Executive Market Consultant

    I would he happy to speak with your group regarding these questions. *****et entry is ...

    1 Hour Later
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    Jose |Vice President - Regulatory Affairs and

    Hello - all the aspects ***** your request are part of my 17 years in medical devices. All aspec...

    1.4 Hours Later
+17 Other Responses
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Medical Device Regulatory Affairs & Quality Assurance

To plan, file, and prepare regulatory, and 510k submissions for fda on new or substantially changed products. In addition the incumbent will prepare technical files in support of ce marking, and maintain compliance with applicable device regulations including support of fda udi requirements. Finally the incumbent will serve as regulatory representative on selected project teams for new product design as well as project teams for process development, developing departmental sops/policies regarding regulatory requirements and processes. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered. Job responsibilities: manage daily activities of regulatory affairs and quality assurance personnel implement all regulatory and quality assurance activities according to in-house procedures and regulatory requirements establish qa procedures for internal and vendor compliance with the fda and international regulatory requirements, quality regulations and guidelines communicate with regulatory agencies; provide oversight to ensure that the company is 100% compliant with us and international regulatory requirements lead regulatory affairs and quality assurance during fda inspections, notified body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits determine the types of regulatory submissions or internal documentation that are required, in situations such as proposed device changes, and maintain regulatory clearances and approvals with necessary filings and communications prepare fda premarket submissions (including fda 510k) and technical files as required for new and updated products qualifications: **must haves** bachelor’s degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required. Must have direct, lead role fda/iso audit experience must have proven ability to prepare and submit documents to fda, such as 510(k) premarket notifications, investigational device exemptions (ides), and premarket approval applications, (pmas); must have proven successful ce marking of devices through design dossier or technical file process. Location: greater philadelphia area, pa

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    Monther |President

    Hi, I'll be glad to assist you with all your *****irs tasks/activities. I have over 20 yea...

    4.2 Hours Later
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    Sharon |Principal Consultant

    Attached please my resume for your review and consideration. Please contact me to discuss this caree...

    7.9 Hours Later
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    RONOC IP |Owner

    Resume attached...

    19.3 Hours Later
+25 Other Responses
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Laac Medical Devices

We are interested to speak with multiple experts who are executives, directors, vps, senior principals, and senior managers to better understand the current device options for left atrial appendage closure procedures, unmet needs associated with these procedures/devices as well as learn more about new trends/technologies within the space. An incentive of $250 will be paid to participants for this 1-hour online interview. Please provide a brief answer as to your relevance to the space below: 1. Please describe briefly your role at the company. 2. How familiar are you with left atrial appendage closure (laac) medical devices? Please explain briefly. 3. How familiar are you with new technologies for laac medical devices? **please note that we are only interested in your personal point of view and are not seeking confidential information. ***referrals are highly appreciated

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    Jacques |Head, Wearables

    I have no relevant experience with LAAC devices. Will decline Thanks...

    19.4 Hours Later
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    Ana |EVP and C. Compliance Officer

    I have a extensive experience in various types medical devices, including nuclear medical ***** ...

    1 Day Later
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    Michael |Principal

    I have more than 23 years in Med device product development, including LAA closure technology. ...

    1.7 Days Later
+11 Other Responses
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Medical Devices Survey

Hi, i am the founder & ceo of zintro. We are brainstorming on ways that we can deliver more high quality inquiries in the medical devices space to you. Specifically, we are looking for inquiries that could lead to larger projects as opposed to just micro-consults (although those are ok too.). T would be great if you could help us help you. Specifically: 1. What is the title/department/division/company of individuals we should we target to improve our chances of finding you good prospects? 2. How would you describe the projects? E.G. Medical device quality, 510k submission, etc? Please be as specific as possible. 3. Are there any specific companies/divisions/departments you think we should target? 4. Where are most of your current customers? Near your office? What state, region, country? Thanks so much for your help. Hopefully, we will deliver some good projects to you soon. Stuart

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    Benjamin |Owner

    Stuart, Since I represent a *****racted sales ***** the hospital environment in ...

    35 Minutes Later
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    Don |CBDO

    1. Director, VP or CXO of; innovation, technology, development, business development, strategy, scie...

    1.2 Hours Later
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    Kent |Owner

    Stuart, Thank you for your interest in my skills and expertise in the area of survey research for me...

    1.5 Hours Later
+31 Other Responses
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Design And Prototyping Of Medical Devices

Position description: lead – ortho neuro spine department: r&d lead – ortho neuro spine will be responsible to develop strong talent to grow recon business that includes hips and knee, trauma, spine and navigation. Person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for ortho neuro spine business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 – 100 people • to ensure timely deliverables to our internal customers position description: lead – hospital infrastructure department: r&d lead – hospital infrastructure will be responsible to develop strong talent to grow hospital infrastructure business that includes patient care and handling and operating room -suite product lines. . person will develop strong r&d infrastructure to manufacture, design, prototype, develop products for hospital infrastructure business. Person will also be responsible to develop strong process for development of medical device. Key responsibilities: • develop products and build strong teams • to ensure having the right quality systems compliant to 21cfr820, iso13485 and iec62304 • will be responsible to hire the right talent, build a strong team and engage the team • work closely with us r&d leaders to develop product pipelines and create product roadmap • collaborate with sales & marketing to develop product roadmap • work closely with support groups like ra/qa, finance and hr • lead a team of 50 –75 people • to ensure timely deliverables to our internal customers • capable of ‘thinking outside the box' • proven experience as a project lead/ manager with good supervisory and team work skills in a fast paced/dynamic environment. • have worked on r&d for operating room devices e.G. Surgical lights, video management, tele medicine, beds and stretchers

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    John |CEO

    Please contact me with this inquiry. I would consider helping your company after learning more about...

    11.9 Hours Later
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    Ade |CEO

    Hi Sheetal Thanks for the enquiry but this is not in my field of expertise. Regards Ade...

    23.8 Days Later
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    Benjamin |President/CEO

    Are you searching for an engineer or a more sales and marketing focused candidate?...

    30.1 Days Later
+3 Other Responses
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Medical Device Manufacturing Engineering

Job title: senior manufacturing engineer job type: full - time department: engineering reports to: director of operations location: windham, maine **job details** are you a talented optical medical device manufacturing engineer ready to develop and execute manufacturing process plans for optics component manufacturing, continuously improve processes and plans using tools and methods such as statistical process control (spc) and design of experiments (doe), and conceptualize, design and execute tooling/process requirements? If so then read on! **primary function** - provide mfg. Engineering support of multiple projects - manage apqp planning process for new programs
 - oversee design and development of new products and processes
 - conduct fmea, doe, spc analysis 
 - direct validation activities for new tools, process and equipment
 - develop and submit validation packages for customer approval
 - map work flows and develop process control plans 
- train personnel to transfer new programs to production **education and experience required** - b.S. In mechanical engineering, optical engineering, materials science, and optical engineering, physics, chemical engineering or equivalent experience strongly desired. - 5-8 years’ experience in engineering with experience in a manufacturing environment
 - product development experience specializing in medical device and life science industry - experience in development programs involving class ii & iii medical devices, 3d modeling, - drafting experience using solidworks - experience in iso13485 glp/gmp environment - experience with design tools (solidworks, cad, 6 sigma principles and practices, fmea, statistical analysis, etc.) - knowledge of design verification/validation activities (sterilization, biocompatibility, packaging, aging, etc.) strongly desired. - metal stamping or medical device experience required 
- minitab statistical software
 - apqp process expertise
 - engineering studies analysis - map process control plans
 - written work instruction level documents for manufacturing - ability to work in a team, be proactive, and proven project management skills experience. This is a growth position. If you are a talented optical manufacturing engineer with at least five years of experience working with lean manufacturing and medical devices, then we look forward to your resume! kindly attach your resume along with your response on zintro. We offer: competitive salary, paid holidays, paid vacation, medical insurance, life insurance, supplemental insurance including: dental short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k with employer contribution. Applicants must be authorized to work in the u.S.

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    Mark |President & Founder

    I am very interested in the opportunity to help your company with the manufacturing of optical based...

    1.1 Hours Later
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    Benjamin |Director

    Does this position pay $1,000,000? My current boss is the worst, I need a new opportunity....

    16.3 Hours Later
+3 Other Responses
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Medical Device Development

We are looking for an expert in the area of medical device development, specifically for knowledge in: plasma based therapeutic apheresis column development using antibodies/peptides matrix/antibody coupling options and optimization sterilization processes including aseptic technique versus end-sterilization for these devices knowledge of regulatory issues also a plus.

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    James |General Manager

    Please contact me at *****, as require further ***** response. 20+ years of...

    1.9 Hours Later
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    B |abc

    Dear Inquirer: I am a professional with more than 10 years of experience in Life Science product de...

    2.2 Hours Later
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    Srinivas |Marketing Manager

    Hi, I'm a *****eting executive and product manager experienced in business and product devel...

    12.1 Hours Later
+10 Other Responses
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Medical Device Prototype

Looking to design and manufacture a proof of concept alpha prototype for a medical device work with compressed air and abrasive powder for a dentalooking for subject matter expert (individual, team, or company) who can design, develop and build an alpha-prototype a device for dental surgical procedure based on our ip. The device utilizes abrasive powder under pressure in a focused controlled pattern to perform the invasive procedure in oral cavity. The rfp will include the design and alpha prototype, manufacture of 1) a handheld operative hand piece or “working head” and 2) a controlled “pneumatic power control unit” which would include compressed air and vacuum source, abrasive powder distribution reservoir, rinse system (reservoir and pump), pressure/vacuum gauges analog or digital, regulators, control valves, control panel, fittings/tubing, electrical wiring and chassis. Required expertise includes but not limited to • cad design through solidworks or similar software to prepare a 3d design of the assembly and components/subassembly prints for manufacturing • mechanical engineering, r&d, and product development experience preferably in the medical device industry. • innovative strategist and problem solver who can develop customized, effective solutions to meet needs in challenging user requirements and mitigate procedural risk through design. • ability to coordinates manufacturing/assembly, and testing to achieve client’s objectives on time, within budget, and to specification. • fluidic designs: such as micro-fluidics, valves, manifolds, pumps-(e.G. Precision aspirate/dispense, diaphragm, solenoid, syringe, piston) reaction and mixing chambers, flow-cells, aspirate/dispense probes, fittings, tubing, flow calculations. • pneumatic design: pneumatic power modules, motion/transfer devices, valves, manifolds, fittings, tubing, compressed air calculationsl procedure. Need a consulting firm who can develop a cad design, perform engineering analysis, prepare specifications of the design and source manufacturing of the alpha prototype and test the device for expected performance

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    Shinoop |CEO

    I am a industrial designer. Since last four years i am professional in Autocad and solidworks 3D mo...

    1 Minute Later
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    Guillermo |Software Developer

    I can help you in developing software for medical ***** you need it, we specialize in de...

    1 Minute Later
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    Pete |Innovation Consultant + Principal

    Hi. I'm a product *****ultant that specializes in the design and development of new produ...

    1 Minute Later
+16 Other Responses
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Medical Device Reimbursement

We are looking for reimbursement experts also called payers experts who have experience getting a medical device approved with one of the european agences such as with germany's bfarm or emea, aemps in spain, aifa in italy, nice in england, or has in france. You do not have to work for these agencies but we need someone who has worked closely with the process of getting a medical device approved with one of these agencies. The product we are working on is for chronic rhinosinusitis and the device involves a laser for the patient. We would like to interview you for one hour about this process. Please send me a detailed reply on your experience with getting medical devices approved in europe overall or in a particular country. Also do you have experience with rhinosinusitis? Please be very detailed so we can determine if you have the right experience. Janet *****

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    Mathieu |Experts for the medtech industry

    Dear Janet, at MD101 we have different medical device experts that can help you bringing your syste...

    15.7 Days Later
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    Yuri |CEO

    I have developed some medical products, till class III. My last product, developed from idea to cert...

    48.3 Days Later
+2 Other Responses
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Pennsylvania Medical Devices Engineering

Job title: senior engineer - medical devices this full-time job post has been authorized by zintro. Competitive salary and benefits. Relocation offered. Senior design engineer directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering project within area of assigned responsibility by performing the following duties personally or through subordinate supervisors. Designs, drafts layouts and drawings of medical devices, assemblies, and systems from specifications, source control drawings, sketches, models, prototypes or verbal instructions for both new and existing product design. **confidentiality**: this position requires strict confidentiality. The senior design engineer will be privy to sensitive company records, as well as the executive managements personal, private information. Information in these areas will not be discussed with anyone inside or outside the company. Confidentiality is a condition of continued employment. Additionally, to apply for this position, the candidate cannot have any on-going non-compete agreements. Additional details of job description available upon request. Qualifications: **must haves** - b. S. Mechanical engineering or equivalent. - minimum of 7-10 developing medical devices and design engineering experience is required. - excellent attention to detail and ability to multi-task. - strong written and verbal communication skills. - highly proficient in microsoft office programs. - must be able to work with customers to define and document requirements, - address technical concerns and provide project status. - ability to make technical presentations internally and to customers. - able to work with minimal supervision, both alone and in teams. - strong project management experience. ** desired** - basic knowledge of anatomy and physiology - background in medical device industry a plus. - background in medical designs a plus. - may assist in overseeing and assigning work to other positions. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Competitive salary and benefits. Relocation offered.

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    Rob |Zintro Expert

    I've designed and tested numerous medical devices for pre-clinical testing, clinical trials, and FDA...

    4.4 Hours Later
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    Muluken |Zintro Expert

    Highly experienced mechanical engineer with more than 7 years invaluable work experience of successf...

    10.9 Days Later
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    Frederick |Zintro Expert

    Over 15 years design, development and production experience, including test and vendor management....

    11.3 Days Later
+8 Other Responses
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the monitoring of various devices via wireless signals from remote locations

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