Sej

/Sebastian

About Sebastian

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So far Sebastian has created 58 blog entries.

August 2018

Independent Manufacturer’s Representatives (I.M.R.s) Wanted

2018-08-03T14:40:05+00:00

Ambitious Independent Sales Representatives wanted!

Internationally known medical device company seeks high-energy, driven I.M.R.s for its customer-focused U.S. sales organization. Sales position involves marketing time tested, consumable use products to the hospital and outpatient setting. Call Points include: Radiology- CT, Ultrasound, Mammography, MRI, Special Procedures/I.R., Vascular Surgery, and Materials Management. “Best in class” devices include Physician focused products specific to all call points.

We Offer

  • Highly competitive commission structure for hungry I.M.R.s paid on shipments
  • Extensive training and field support provided by 20-year management team
  • In-house agile marketing team with experience in medical device business
  • International environment with informal corporate culture

The Ideal Candidate

  • Previous IMR and 1099 experience preferred
  • Professional medical device sales experience
  • Interventional Vascular in Thrombectomy space a plus
  • Established hospital contacts and relationships in this market are required

Please send your application to jat@mermaidmedical.com

Product Quality Engineer

2018-08-03T14:23:52+00:00

For our HQ in Stenløse, Denmark Mermaid Medical A/S is looking for a Product Quality Engineer with solid QA/RA experience. Mermaid Medical A/S is a successful Danish, independently owned, private company founded in 2007. Our global sales force works out of 10 sales offices in Europe, USA and Asia. We design, manufacture and distribute medical devices to hospitals and other end-users. We are ISO 13485:2016, CMDCAS ISO 13485:2003 and MDD/93/42/EEC certified, and FDA registered.

Job description

As a Product Quality Engineer, you will report to the Vice President QA & Regulatory Affairs and you will be part of a QA/RA/R&D team of 3 persons. You will be responsible for creating, documenting, updating and performing product tests and maintain and documenting technical files according to regulatory requirements as well as performing re-qualification on products, processes and equipment.

You will also participate in all Product Development projects to ensure consistent project execution according to QMS system.

Together with the QA/RA team you will prepare the QMS system and technical documentation for the upcoming Medical Device Regulation 2017/745.

Tasks and responsibilities

  • Responsible for creating, documenting, updating and performing product tests and identifying deficiencies
  • Develop statistical rationale for testing in general
  • Testing, identifying root cause, risk analysis assessment and documenting products as part of complaint, vigilance, non-conformance and CAPA case handling
  • Performing re-qualification (verification/validation) of products, processes and equipment
  • Developing and writing protocol and reports in general
  • Planning, creating, updating and maintaining technical files according to regulatory requirements (product standards, statistics, MDD, MDR, FDA, Canada, Asia etc.)
  • Participating in Design Control projects to ensure consistent project execution according to QMS system
  • Analyzing
  • Collect quality data in various cases
  • Prepare QMS system and technical files for regulatory requirements including UDI and labeling requirements

The ideal candidate

  • An engineer or bachelor’s degree or other relevant technical background
  • 3-5 years of experience as Product Quality Engineer or similar
  • Experience with Medical Device products (vascular or non-vascular products (interventional radiology and urology) will be an advantage)
  • 3-5 years of experience with a variety of different testing techniques and statistics
  • Experience with ISO 13485, ISO 14971, ISO 62366, ISO 60601, FDA requirements
  • Good investigative and problem-solving skills with excellent attention to technical details
  • Sense of ownership and pride in your performance and its impact on company’s success
  • Critical thinker
  • Team player
  • Good time-management/planning and systematic skills
  • Great interpersonal and communication skills
  • Excellent English skills both in writing and verbally. All documentation must be in English
  • IT skills (ERP systems like Navision or other related databases)

We offer you

  • Highly specialized and talented colleagues
  • Informal corporate culture
  • International environment
  • Competitive salary package incl. pension and healthcare insurance
  • Lunch arrangement
  • Social events and fun activities
  • Paid fitness

If you think this is just the job for you, please send your application to ajn@mermaidmedical.dk before August 31, 2018.

If any questions, please contact Pia Wissing Jensen – Vice President QA & Regulatory Affairs – e-mail: pwj@mermaidmedical.dk.

 

January 2017

Mermaid Medical Group Supports The Danish Refugee Council

2017-06-27T06:48:01+00:00

Again this year the Mermaid Medical Group supports the The Danish Refugee Council.

There are more refugees in the world than ever, in fact more than 45 million people are displaced from their homes all over the world and they need help. The Danish Refugee Council distributes emergency relief and promotes lasting solutions to refugee problems to approximately 2 million displaced people in more than 30 conflict affected countries. Mermaid Medical supports this work through a business partnership which includes a yearly donation to the Danish Refugee Council.

The Danish Refugee Council (DRC) is a humanitarian, non-governmental, non-profit organisation working in more than 30 countries throughout the world. The Danish Refugee Council is currently implementing a broad range of activities relevant to conflict affected communities and persons. The activities are categorized in ten sectors: Shelter and Non-food Items, Food Security, Protection, Income Generation, Coordination & Operational Services, Community Infrastructure & Services, Humanitarian Mine Action, Armed Violence Reduction (AVR), Water, Sanitation & Hygiene (WASH), and Education.
Danish Refugee Council

December 2016

Introducing Tumark Vision Clip Marker

2017-09-21T09:21:28+00:00

Tumark Vision enables precise marking of breast lesions. The unique spherical shape and wire mesh structure lead to high echogenicity in any position under ultrasound imaging. The non-resorbing and self-expanding marker material nitinol enables long-term stability and visibility.

Tumark Vision Clip Marker

Tumark Vision Features

Tumark Vision Clip Marker close-up

Tumark Vision visibility under Mammography, Tomosynthesis and Ultrasound

Tumark Vision Mammography
Tumark Vision Tomosynthesis
Tumark Vision Ultrasound

Please contact your local representative or go to the product site for more information about the product.

September 2016

Introducing M•Fixx™ Catheter Securement Device with Hydrocolloid Core

2017-06-27T06:48:01+00:00

As part of the continuing expansion of our M•Drain™ product line, we are pleased to announce the addition of M•Fixx™ Catheter Securement Device with a Hydrocolloid Core. The M•Fixx™ Catheter Securement Device is for safely anchoring percutaneous drainage catheters ranging from 5 Fr to 16 Fr.

M•Fixx™ is truly a product that has been developed in cooperation with the customers, and with the clinical personal and patients in focus.

The low profile design allows free flowing drainage during the life of the M•Fixx™ with very little attention from the user. The hydrocolloid core provides improved patient comfort and absorbs body fluids from puncture site. The M•Fixx™ is sterile, latex and phthalate free.

Article number
A20100090: 6.5cm x 8.0cm, 25pcs per box

Please contact your local representative or go to the product site for more information about the product.

July 2016

Scion Medical Technologies and Mermaid Medical Group Enter Global Distribution Agreement to Distribute Cassi™ Rotational Core Ultrasound Biopsy Device and Beacon™ Tissue Marker

2017-06-27T06:48:02+00:00

Scion Medical Technologies, a China-based global medical device company, today announced it entered into an exclusive global distributor agreement with Mermaid Medical, a leading medical device company with major focus in breast care and women’s health. With this agreement, Scion Medical Technologies will further extend the availability of its patented Cassi™ Rotational Core Ultrasound Biopsy Device and Beacon™ Tissue Marker.

Cassi™ is a hand-held, self-contained rotational core ultrasound biopsy device that provides accurate target tissue sampling while delivering more biopsy tissue in fewer passes. One of Cassi’s advantages is its patented Stick-Freeze Technology™ which immobilizes the lesion and secures the tissue for sample collection.

Beacon™ is a nonmetallic tissue marker and is biocompatible for permanent placement within breast tissue. The Beacon breast tissue marker is designed to provide permanent visualization under the major imaging modalities: ultrasound, mammography (X-Ray) and MRI.

According to David Chen, Chairman and CEO of Scion Medical Technologies, “We are excited to be able to partner with Mermaid Medical because of its experience as a medical device distributor, in-depth knowledge of breast biopsy market, as well as its dedicated sales team in Europe and USA. We believe this alliance will enable us to deliver our innovative tools to the healthcare professionals to enhance patient care.”

Mermaid Medical Group has its focus on Breast care and women’s health with a dedicated direct sales force in all major European markets and in the USA. Other markets are supported by well-established distributors. “The partnership with Scion Medical Technologies is the perfect match for Mermaid Medical’s strategy of building up a first class breast product portfolio and we have high hopes of the cooperation and selling of CassiTM and the non-metalic BeaconTM marker for ultrasound, mammography (X-Ray), MRI and tomosynthesis” said Lars Vinther, CEO of Mermaid Medical. “The Scion product line is a perfect match with the R&D pipeline that Mermaid Medical will release over the next 12 months.”

Scion Medical Technologies engaged Medical Device Incubator and Technology Brokerage firm, Hatch Medical LLC to broker the transaction.

About Scion Medical Technologies
Scion Medical Technologies (Scion) is a global medical device company with operations in USA and China. Scion has a portfolio of products with marketing clearance which are sold in the US, Europe and Asia both directly by Scion and through distribution partners. Scion is a fully integrated company with two manufacturing facilities in China as well as R&D, distribution and regulatory expertise. The Company has grown mainly through product acquisition and partnering transactions with both midsize and large multinational companies. Scion’s expertise is in minimally invasive procedures with a focus on products used mainly by interventional radiologists and surgeons.

About Mermaid Medical
Mermaid Medical Group is a private and independently owned company founded in 2007 and headquartered in Copenhagen, Denmark. Mermaid is a global manufacturer and distributor of medical devices and has its main focus on breast care and women’s health, interventional radiology & cardiology and ultrasound interventions.

Within our areas of business we strive to be the preferred partner for both manufacturers of medical devices as well as end-users in the healthcare sector. Mermaid Medical Group is the exclusive distributor for several world-leading manufacturers of medical devices and supply medical devices to hospitals and other end-users.

June 2016

Surgical Specialties Corporation Announces Approval of Expanded Use for BioSentry™ Track Sealant System in Europe

2017-06-27T06:48:03+00:00

Braintree, MA – May 20, 2016 – Surgical Specialties Corporation (Surgical Specialties), a leading provider of branded, private label, and OEM medical devices for advanced surgery, wound closure, ophthalmology, and radiology announced today approval for expanded European labeling for its BioSentryTM Track Sealant System. This approval expands the number of patients that can benefit from this technology now that it can be used with a larger 17 gauge biopsy system. This important change allows a significantly greater number of percutaneous transthoracic lung biopsy procedures to be able to use BioSentry™, which is proven to reduce the risk of pneumothorax and subsequent adverse events.

Mermaid Medical Proudly Introduces the Endoscopic Marker Injection Needle

2017-06-27T06:48:03+00:00

While the success of an endoscopic tattoo strongly depends on injecting with the right depth Mermaid Medical developed a specific endoscopic needle for marking the Gastro Intestinal tract with endoscopic markers like SPOT. This sharp, flexible needle has the right needle length for secure and safe submucosal injection.

Contact your local Mermaid Medical representative for your introduction offer on this new Mermaid Medical product.

April 2016

Having Trouble Examining Open Wounds?

2017-06-27T06:48:04+00:00

The next generation of sterile barriers has expanded. Introducing a new sterile hydrogel dressing from Civco Medical Solutions.

HydroAid® sterile hydrogel dressing is applied as a protector of skin and wounds and can be used as a scanning standoff between a transducer and a patient’s skin in the course of ultrasound diagnostics.

With a sterile HydroAid® hydrogel pad, it is possible to examine the open wounds where the use of liquid gels is not possible. HydroAid® is also used in the sonography of irregular surfaces and other areas to improve the visibility of surface structures or where it is difficult to conduct local examinations.

Please contact your local representative or go to the product site for more information about the availability.

Click here to find the product sheet

February 2016

Mermaid Medical Group Supports the work of Families of Children with Cancer

2016-02-08T14:24:53+00:00

Again this year the Mermaid Medical Group supports the important work of Families of Children with Cancer. Any donations makes a huge difference to families of children with cancer. The organization provides opportunities for families to get out and meet people going through common experiences while in treatment or out of treatment. These are great opportunities for families to get away from the life of pokes, pills, thinking about doses of chemo in order to enjoy a fun event as a family.
Last year’s activities covered excursions to Legoland, circus performances, football matches with the Danish top teams and lots of other social events.