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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
  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 Fda Medical Device Inquiries

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Medical Device Packaging

We are looking for a medical device packaging consultant who can take us through all the regulatory requirements (validation protocols and testing included).

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    Steve |Director of Supply Chain, Strategic Sour

    Experienced *****ocol and testing consultant...

    1.5 Hours Later
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    Alberto |Zintro Expert

    Hi, Usually the *****irements should cover IQ, OQ, and PQ (Protocol and Report). These r...

    1.7 Hours Later
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    Len |Consultant

    15 years of engineering and *****rience in developing class I-III, medical Device products...

    1.7 Hours Later
+32 Other Responses
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Margin Analysis In Pharma And Medical Device Distribution

Margin analysis for entities involved in the distribution of medical devices and pharmaceuticals. Need 2 experts, one each for europe and southeast asian region. We are currently doing a margin analysis for entities involved in the distribution (value chain) of medical devices and pharmaceuticals. We segmented the 2 markets by different product categories. What we are precisely looking for is manufacturers and distributor / wholesaler margins and just a ballpark figure / range for the whole region by segments.

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    Simona |Business Consultant/Financial/HR Manager

    Hi ,I can help you from Europe. Regards,...

    6.2 Hours Later
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    Benita Saklani |Head Of Business Development

    I am from India...

    7.7 Hours Later
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    Aravind |Business Leader

    Hi, Im a chemical consultant with over 15 years of experience in working with a wide range of market...

    18.6 Hours Later
+16 Other Responses
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Medical Device Packaging

Alternate to tyvek sterile barrier packaging for medical device company

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    Sunder |Consultant

    I have 30 years of experience with sterile medical device packaging. I have used Tyvek extensively. ...

    19.5 Hours Later
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    Olivier |Packaging Development Manager

    Which kind of packaging process ? Which kind of *****ess ?...

    5.9 Days Later
+2 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 Devices Packaging

We are looking for experts on medical devices packaging to understand the information related to primary packaging procurement. Please find specific questions below: 1.How is packaging supplier performance measured by medical device manufacturers? 2.Do global medical device companies have regional r&d centres for packaging? 3.Is there a sustainability engineering department in medical device manufacturers? 4.How is the burden of feedstock commodity price changes reflected? 5.Do medical device manufacturers engage with global or regional suppliers? And why? 6.What are the outsourcing strategies they adopt for tail spend? 7.Do healthcare customers value sustainability? How do they measure it? 8.What is more important for the customer- cost or sustainability? Are they willing to pay for it? This is a ad-hoc request with time constraint and hence any quick replies are appreciated. Thank you.

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    Emrah |R&D Manager

    quote attached....

    8.2 Hours Later
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    Michael |Packaging Engineer & Consultant

    Hello. We would enjoy discussing primary packaging procurement for medical devices further. Feel fre...

    8.5 Hours Later
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    Garret |Principal Packaging Engineer

    Up to 1 hour phone cal...

    8.6 Hours Later
+26 Other Responses
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Medical Device Cast Film Packaging

I am looking for a phone consultation medical device packaging industry needs and market openings for cast film. My company produces cast film and recently installed and is scaling up a thin gauge cast sheet line.

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    Douglas |Polymer Material and Processing Scientis

    Can't provide industry feedback from the pharmaceutical packaging industry ...

    1.6 Hours Later
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    Boris |CEO

    I can offer you over 30 years of experience in packaging of pharmaceutical, medical and other produc...

    2.5 Hours Later
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    Philip |Consultant

    I have compounding, process, and product development expertise in calendared thermoformable PVC and ...

    1 Day Later
+9 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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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 Packaging

I am seeking package design expertise for an implantable medical device that is radiation sterilized. The device is already approved and we would like to reduce the package size and ensure the protection of the primary package contents as well as securing the primary packaging within the secondary package.

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    Terry |VP of New Business Development

    Please contact us at ***** Sincerly Terry Luzier Print Management...

    46 Minutes Later
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    Arnold |Founder & President

    Where are you located?...

    51 Minutes Later
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    Rohit |CEO & Founder

    My team brings collective experience of over 15+ years in the field of medical, optoelectronics and ...

    1.4 Hours Later
+27 Other Responses
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Automation

This is a full-time job opportunity as a automation engineer, located in marlboro, massachusetts. Interested candidates must attach their latest resume along with their response/cover letter over here on zintro. ***job description: we are looking for an automation engineer with experience in development, commissioning and maintaining of automated work cells for manufacturing medical devices. This position will offer the opportunity to work with specialized equipment for high throughput medical device manufacturing in a close team-work environment with engineers, scientists and technicians. Reports to: director, manufacturing engineering *** key responsibilities: - support start-up and commissioning of equipment and work cells for medical device manufacturing - developing drawing and detailed technical documentation with specifications - maintenance of manufacturing equipment, including plc programming, automation and trouble shooting - integrate several pieces of equipment together under one control system/workcell - specify equipment and suppliers capable of performing needed processes, capable within required tolerances. - develop and execute protocols for validation of processes; installation, operational, and process qualifications. - manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing and set up of new equipment. - work closely with cross functional teams to improve process efficiencies, product quality and reduce costs - train and support personnel on equipment, automation and work instructions. ***education/experience requirements: - bachelor’s degree in engineering, computer, science or related technological field - 5+ years of relevant work experience in automation, experience in operations/manufacturing environment, preferably medical devices. - good hands-on systems integration experience, plc and hmi programming and configuration, troubleshooting, and start-up and commissioning of work cells - multi-disciplined engineering understanding of manufacturing, mechanical, electrical, software, etc. Engineering principles. - good knowledge of a) plc programming proficiency b) industrial communications c) material handling and machine automation d) drive systems e) vision systems and control loops f) integration of different equipment aspects (software and hardware). - familiar with manufacturing processes like laser welding, heat staking, engraving and plastics processing - experience and knowledge in manufacturing products under iso 13485, and fda/cgmp/gamp software validation procedures or similar regulated environment - exposure to or direct experience with regulated environments (i.E. Osha, epa) - a team-oriented player who collaborates and communicates effectively in a cross-functional, multi-cultural, interdisciplinary environment - experience in managing small to medium-sized projects. - experience authoring and reviewing standard operating procedures, work instructions and other controlled documents. Interested candidates must attach their latest resume along with their response/cover letter over here on zintro. Note: this full-time job does not provide visa sponsorship.

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    John |Principle & Senior Consultant

    JOHN ZEDICK, MBA, FACHE, CMQ/OE 1061 Windsor Creek Drive, Grayson, GA ***** H ***** C *****...

    1 Day Later
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    Alexandre Guimarães |

    Dear Hiring Manager, I feel that my skills and experience are a great fit for this position. Work...

    22.8 Days Later
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    Steven |

    Dear Hiring Manager, I am a medical device engineer with deep experience in equipment and tooling f...

    24.7 Days Later
+9 Other Responses
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Medical Device Patents

I am looking for a patent engineer or attorney to help with my start-up company finishing up a patent which has already been initiated. The product is a medical device which is regulated by u.S. Fda. There is no fee that can be paid at this time however, we are willing to trade company shares and equity in lieu of direct payment. How would this type of process be accomplished within the zintro environment? Umberto v. Parrotta

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    Robert |PhD, PE

    Let's talk. Maybe I can help....

    6.1 Hours Later
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    Gerard |President, CEO and Chairman of the Board

    I have 20+ years experience as a parent attorney and am CEO of my own medical device co. I'd be happ...

    7.9 Hours Later
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    Suddha |Consultant

    I am interested, willing to work in lieu of sweat equity....

    18.4 Hours Later
+7 Other Responses
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