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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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Hermetic Feed-throughs For Medical Devices

We are interested in a ~1 hour phone call with an expert on connectors in hermetically sealed electrical or optical medical devices, specifically glass to metal seals with feed-throughs if possible. We’re interested in speaking with medical device design engineers, manufacturers of the seal assemblies, or anyone else with intimate knowledge of the technology. We’d like to learn about the market (applications, manufacturing companies, pricing, etc.), the technology itself (materials used, manufacturing process, common problems in medical devices), or both. Thanks!

    +undefined Other Responses
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    Medical Device Program Management

    This job post has been authorized by zintro. The program manager should have many years of experience around managing oem product development programs specific to the optical endoscope medical device market. Assume overall accountability for all aspects of a project and ensure success. Serve as liaison and central point of contact for client, vendors, management and engineering. Apply expertise to coordinate cross-functional project team activities, ensure timely completion of tasks and deliverables, and meet project deadlines and objectives. Advise the product engineering team on decisions regarding which deliverables are critical to the success of the project and prioritize accordingly. Additional details of job description available upon request. **essential knowledge, skills & abilities** • special knowledge, skills and abilities: • demonstrated project leadership for new product development of medical devices • demonstrated experience working within iso 13485 and 9001 • experience managing multiple development projects simultaneously • demonstrated experience with tools such as fmea, risk analysis, time and budget tracking, scheduling, prioritization • excellent written and verbal skills. Must clearly communicate with team members, clients, vendors, and senior management regarding technical details and projects status • good organizational, multi-tasking and team building skills • demonstrated design experience in area of engineering expertise as well as broad practical knowledge of related disciplines • strong ms project user, understand dependencies, critical path • manage internal/external technical resources **must have** • bachelors degree or significant experience in a technical discipline is preferable • minimum 8 years of product development and project engineering experience • many years of experience around managing oem product development programs specific to the optical endoscope medical device market. **we offer** • competitive pay, paid holidays, paid vacations, medical insurance, life insurance, supplemental insurance including: short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k plan, direct deposit. Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting. Must be authorized to work in usa.

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      Alex |IIP Consultant linkedin.com/in/Alexander

      Hi, sounds interesting, have a look at my LinkedIn profile AlexanderWeir Kind regards, Alex...

      3 Hours Later
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      David |Zintro Expert

      I would be interested in more detail, firm, scpe & type of product...

      3.8 Hours Later
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      Mahzad |Mechanical Engineering & Design Consulta

      I have 30 years ***** diving continuous improvement and plant wide *****ect manag...

      20.6 Hours Later
    +40 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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      A |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
    +11 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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      Medical Device Prototype

      Looking 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 calculations location: usa

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        Christoph |PhD

        Dear Sir or Madam, I am very interested in this project. Please review my *****r: ww...

        1 Minute Later
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        Shailesh |Independent Consultant

        Hello, I work with an Engineering Services firm which can actually provide you with the kind of en...

        1 Minute Later
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        mark |President

        We can help. Our firm has been in medical part design and build for almost 30 years. Bonifacio Consu...

        1 Minute Later
      +16 Other Responses
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      Medical Device Marketing And Strategy

      We are looking for a medical device professional, with a strong background in emergency medical/first responder devices, to help a start-up company develop strategy, valuations and ultimately a licensing agreement, or other arrangement, with a mid-size or major medical device company. Patents, trademarks, preclinical trials (highly successful) and fda pre-market applications either in place or in process. Greater los angeles area preferred.

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        Barry |Principal, VP Marketing, Director Market

        I can assist with your inquiry. Please contact me through Zintro....

        10.5 Hours Later
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        Erik |Senior Consultant

        Hi Medistrat12, I can help with your approach of the European markets, if that would be of interest....

        5.9 Days Later
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        mark |President

        Bonifacio Consulting Services has several consultants 20+ years in medical devices both domestically...

        9.9 Days Later
      +4 Other Responses
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      Medical Device Packaging

      Performs professional engineering work in the conception, specification, design, manufacture and/or testing of packaging materials and products to contain, protect and ship contents. Typically requires a 4-yr degree in mechanical engineering, materials engineering or package engineering. Three (3) years experience. Experience in a medical device manufacturing plant preferred.

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        Curtis |Principal

        I would consider an opportunity of this type. I am experienced in all areas of medical device packag...

        1.1 Hours Later
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        Philip |Consultant

        I can provide expert advice for sterilizable paper/film type packaging and/or thermoformable blister...

        1.5 Hours Later
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        Paula |President/Owner

        I don't do this kind of work. Good luck-...

        1.8 Days Later
      +4 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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        Richard |Consultant

        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

      We are a mid-sized medical device company selling self-injection devices to pharmaceutical companies. We are looking for a business development consultant to identify and schedule meetings with appropriate pharmaceutical companies in south and central america.

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        Mark |Principal

        Depending upon the country(ies) for which you seek market entry, you may need medical device registr...

        14 Minutes Later
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        Leonie |Managing Director

        Hi, We can definitely help you with this endeavor. Our work is predominantly in injectable and i.v...

        4.4 Hours Later
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        Joseph |Managing Director

        I have worked in the development of Sales & Marketing of medical devices to *****ica for 25 yea...

        5.1 Hours Later
      +7 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.

        +undefined 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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