Vacancy Process Development Engineer

Our company

Polyganics is an innovative, privately held medical technology company bringing to market unique bioresorbable devices to facilitate tissue repair and regeneration after surgery. From its ISO 13485-certified manufacturing facility, products are distributed to customers worldwide. Polyganics has recently moved to a new facility at the Zernike Campus, Groningen, which houses its headquarters, state-of-the-art research laboratories and manufacturing and packaging facilities. More information: www.polyganics.com

The job

Polyganics is looking for a Process Development Engineer. As a Process Development Engineer, you will be focusing on the design of production processes and you will support the transfer from prototype to production. You will work in a team of Engineers within the R&PD department, in a cross functional environment and you will report to the Manager Engineering.

Key responsibilities

  • Design and development of new production processes
  • Documentation and qualification of production processes
  • Ensuring that processes and documentation comply with applicable standards and regulations (ISO, GMP, et all)
  • Contributions to projects
  • Initiating technological innovations
  • Assessing safety and process risks and addressing associated controls measures e,g, adjustments of the process or equipment
  • Setting specifications for new equipment

Your profile

  • A Bachelor or Master degree in Chemical Engineering or Process Technology
  • Knowledge of and experience with automated systems
  • Knowledge of standards, guidelines and norms for production of medical devices and or pharma
  • Excellent written and oral communication in English and Dutch
  • Knowledge of polymer chemistry is an advantage
  • Critical, conceptual and analytical thinker
  • Able to see new possibilities
  • Attention to detail and quality
  • Self-starter and team-player with good interpersonal skills

Our offer
We offer a dynamic position in a growing organization with the opportunity to develop yourself. Polyganics has a professional but informal working environment and a pleasant work atmosphere. We offer a competitive salary and good secondary benefits.

Would you like more information?

Please contact Mrs. Marleen Schoonen (HR) +31-50-588 6 588

You can send your application to hrm@polyganics.com.

Headhunters and recruiters need not apply.

 

Manager Backoffice and Customer Support, Groningen – office based

Our company
Polyganics is an innovative, privately-held medical technology company that develops, produces and markets unique bioresorbable devices. Our products facilitate tissue repair and regeneration after surgery. From our ISO 13485-certified state-of-the-art research laboratories and manufacturing and packaging facilities, products are distributed to customers worldwide. More information: www.polyganics.com

The job
You will be responsible for customer support and will lead Polyganics’ back office and managerial support team. In addition, you will directly interact with visitors of Polyganics’ office in Groningen and, from this location, with key customers worldwide. You will report to the Chief Operational Officer and closely work with the Sales Director and Director Marketing and Business Development.

Key responsibilities
* Ensure customer-oriented service
* Make sure that contract deliverables and deadlines are adequately met
* Support in sales and marketing processes; such as control of marketing material, document control, monitoring of orders and tracking of shipments
* Coordinate and lead all office management activities, ensuring that office management operates smoothly and efficiently
* Overseeing management support staff, receiving and directing visitors, and handling or delegating basic office management tasks.

Your profile
* Bachelor degree
* Demonstrated experience with customer support & service and preferably with office management as well
* Excellent organizational skills and interpersonal skills, strong attention to detail and the ability to set priorities within a dynamic environment
* Excellent verbal and writing communication skills, both in Dutch and English
* Ability to manage your workload and supervise others concurrently
* Essential social media and marketing experience
* Experience in the medical device industry, experience with SAP and proficiency in the German language (oral and written) are an asset.


Our offer

We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself. Polyganics has a professional but informal working environment and a pleasant work atmosphere. We offer a competitive salary and good secondary benefits.

Would you like more information?
Please contact Mrs. Henne Barkema (HR) +31 (0)6 52 0616 35.
You can send your resume with a short motivation to hrm@polyganics.com.

Manager Backoffice and Customer Service

Recruiters and headhunters need not apply.

Vacature Operator allround / technician

Ons bedrijf
Polyganics ontwikkelt, produceert en verkoopt wereldwijd biologisch afbreekbare medische producten. Onze producten worden gemaakt van bio-afbreekbare synthetische polymeren. Ze worden door het lichaam afgebroken, waardoor er na een operatie in een later stadium geen chirurgische ingreep meer nodig is om ze te verwijderen. Dat maakt onze producten zeer patiëntvriendelijk, veilig en kostenbesparend.

Wat houdt deze baan in?
De Operator allround is onderdeel van een van de teams binnen de afdeling Operations, maar in deze functie ben je binnen alle teams inzetbaar. Dat betekent dat je in het lab werkt en daarnaast als dat nodig is ook in een van de cleanrooms of bij verpakking.

Jouw taken en verantwoordelijkheden zijn onder andere:
– het produceren van halffabricaten voor medische toepassingen
– het produceren van bio afbreekbare medisch producten bij andere productieprocessen en ondersteunen van testen door R&D
– regelmatig werken in een cleanroom

Wie zoeken wij?
Een leuke, open collega die goed kan samenwerken in een team.
Je hebt:
– minimaal 5 jaar ervaring als Operator bij een medical device of farmaceutische bedrijf
– bij voorkeur ervaring met het werken met polymeren
– bij voorkeur een afgeronde MBO opleiding chemie of ervaring op dat niveau
– je kunt zelfstandig werken, bent nauwkeurig, resultaatgericht en boven alles een plezierige collega

Geïnteresseerd?
Wil je deel uitmaken van een leuke en groeiende organisatie waar ruimte is voor eigen initiatief en ontwikkeling? Dan nodigen wij je uit te solliciteren via hrm@polyganics.com.

Voor meer informatie kun je bellen met Jan Disbergen 050 588 65 88 of met Henne Barkema (HR) 06 520 61 635.
Vacature Operator 2021

Headhunters en (uitzend)bureaus verzoeken wij uitdrukkelijk niet te reageren op deze vacature.

Vacancy Manufacturing engineer

Our company
Polyganics is an innovative medical technology company. We develop, manufacture and commercialize worldwide, innovative bioresorbable devices to facilitate tissue repair and regeneration after surgery. We adapt our versatile polymers for different clinical applications, improving surgical outcome and patient recovery.


The job

As one of our Manufacturing engineers you will be improving our processes and equipment. You will work on  trouble shooting, up-scaling, improving and validation of existing production lines. As we are a medical device company this includes collecting and recording data and writing solid protocols and reports.
Part of the job will be to investigate plant- or process-improvement opportunities. These improvement projects are related to different aspects, e.g. safety, quality, capacity and efficiency.

 
Your profile
We are looking for a team player who will thrive in an entrepreneurial and technology driven business environment.
You have a BSc/MSc degree in chemical/process engineering or equivalent. Five years or more work experience in the manufacturing or process industry / medical device industry and knowledge of GMP / ISO 13485 is preferred.
You have worked with polymers before. Experience with Lean Six Sigma or statistics is an important asset.
This full-time position demands a high level of interpersonal skills, robust analytical skills, proactivity, personal integrity and excellent written communication skills in English.

Our offer
We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself.
Polyganics has a professional but informal working environment and a pleasant work atmosphere. We offer a competitive salary, good secondary benefits and support your efforts to improve yourself.

Would you like more information?
Please contact Harm de Vries, Manager +31 (0)50 588 6588 or Henne Barkema (HR) +31 (0)6 52 0616 35.

You can send your resume with a short motivation to hrm@polyganics.com

Vacancy manufacturing engineer 2021

Recruiters and headhunters need not apply.

Vacancy Regulatory Affairs Associate

Our company

Polyganics is an innovative medical technology company. We develop, manufacture and commercialize worldwide, innovative bioresorbable devices to facilitate tissue repair and regeneration after surgery. We adapt our versatile polymers for different clinical applications, improving surgical outcome and patient recovery.

The job

As Regulatory affairs associate you will prepare submissions (CE, IDE, PMA) of high-risk medical devices. You manage preparation of new regulatory documents and dossiers to enable new products to be launched and maintained in the market, with the correct alignment and compliance to regulations. You provide support with change notifications and initiate and maintain technical files and registrations. You perform vigilance / medical device reporting.

Your profile

– We are looking for an associate who maintains current knowledge of medical device regulations, guidance and standards applicable to product submissions.

– You understand and have working knowledge of FDA medical device regulations, European Medical Device Directives/Regulation, and/or other global regulations. – You demonstrated working knowledge of scientific principles.

– You have a Bachelor or Master degree in Regulatory Affairs or related discipline and up to three years work experience in a similar function. This position demands a high level of interpersonal skills, personal integrity and excellent written communication skills in English.

Our offer

We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself. Polyganics has a professional but informal working environment and a pleasant work atmosphere.

We offer a competitive salary, good secondary benefits and support your efforts to improve yourself.

Would you like more information? Please contact Ms. Betty IJmker, director QA/RA at+31 (0)50 588 65 88 or Ms. Henne Barkema (HR) at +31 (0)6 520 61 635.

You can send your resume with a short motivation to hrm@polyganics.com

Vacancy RA Associate 2021

 

Recruiters and headhunters need not apply.

First Patient Treated in Polyganics’ ENCASE II Trial for Innovative Dura Sealant Patch, LIQOSEAL

Randomized controlled trial in the US and Europe will enable LIQOSEAL to be submitted for FDA approval

Groningen, The Netherlands, May 21 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced treatment of the first patient in its ENCASE II clinical trial for LIQOSEAL.

LIQOSEAL is an easy-to-use, synthetic dura sealant patch indicated for use as an adjunct to standard methods of cranial dural repair, to provide watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) leakage. In addition, LIQOSEAL also supports regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’).

ENCASE II is randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing intra- or post-operative CSF leakage in patients undergoing elective cranial surgery. The trial will involve 228 patients, enrolled and treated at up to 20 clinical centres across the US and Europe. Patients will be randomly treated at a 1:1 ratio with either LIQOSEAL or an FDA-approved sealant as a control.

Polyganics achieved CE mark certification for LIQOSEAL in early 2020, based on positive 3-month data from its ENCASE I clinical trial, and immediately launched the device in Europe. The Company has seen good uptake, and now, just over a year after the initial launch, LIQOSEAL is commercially available throughout Europe via a dedicated network of distribution partners and is registered for use in other countries including Turkey, Israel, Jordan, Argentina. Other registrations are also in progress.

Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, New Mexico, and Global Coordinating Investigator for the study commented: “Cerebrospinal fluid leakage is one of the most common complications of neurosurgical procedures and a significant burden to patients and healthcare systems. LIQOSEAL is a potentially game-changing device, which may offer a unique opportunity to make a meaningful impact on the lives of patients by reducing these CSF leak rates. I am excited to be part of the ENCASE II study where we are rigorously testing this hypothesis.”

Prof. Dr. Med. Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, and Coordinating Investigator for the study in Europe said: “Having worked on the LIQOSEAL project since inception, I am proud that the device is now entering this large-scale ENCASE II clinical trial. I was delighted with the follow-up results of ENCASE I, showing that there was no CSF leakage and no clinically significant swelling, while there were no device-related adverse events following the first 40 LIQOSEAL surgeries. I am pleased to continue playing my part to critically study this device, ultimately to maximally reduce CSF leakage in our patients.”

Rudy Mareel, CEO of Polyganics, added: “Despite many COVID-related delays to elective procedures during the past year, we are happy that Polyganics has seen strong interest and uptake of LIQOSEAL throughout Europe and in other countries. We are proud to have numerous world-renowned clinical centres participating in our ENCASE II study. They are a testament to the unique, life-altering potential of our dura sealant device.”

– ENDS –

 

For more information please contact:

Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com

 

Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com

 

Notes to editors

 

About Polyganics

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.

Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. The portfolio includes marketed products in the fields of Peripheral Nerve Repair (PNR) and Neurosurgery: VIVOSORB®, for minimizing unwanted tissue adhesions after surgery; NEUROLAC®, for supporting PNR following hand surgery; NEUROCAP®, for the management of symptomatic neuromas; and LIQOSEAL®, a dura sealant patch for the effective control of cerebrospinal fluid leakage. Products in development include ACTISEAL®, a Liver and Pancreas Sealant Patch in the field of General Surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE® and NASOPORE-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker.

Polyganics is a privately held company based in Groningen, The Netherlands. The Company is ISO 13485-certified, and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.

For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV

 

About CSF leakage

Cerebrospinal fluid (CSF) leakage is a widely recognized complication of neurosurgical procedures. It represents a significant patient burden, resulting in increased morbidity, prolonged hospital stays, possible surgical revisions, and enhanced costs.1,2 Incidence rates vary depending on age, indication, location of surgery and underlying pathology, but in total CSF leakage occurs in 4-32% of surgical cases.3,4

 

About LIQOSEAL

LIQOSEAL® is a safe and easy-to-use patch indicated for use as an adjunct to standard methods of cranial dural repair during surgery. By ensuring watertight closure of the dura mater, the patch provides effective control of CSF leakage throughout the critical healing period, as well as supporting regeneration of the dura mater by acting as a scaffold for new fibrotic layer formation (‘neodura’). The patch uses Polyganics’ proven proprietary synthetic bioresorbable polymer technology. It is commercially available throughout Europe and in selected other countries via a network of experienced distributors.

For more information, visit: https://polyganics.com/portfolio/neurosurgery/

 

References

  1. Hutter G, von Felten S, Sailer M, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece bound tissue sealing against dural suturing alone: a randomized controlled trial. Neurosurgery. 2014. Sep; 121:724-744
  2. Grotenhuis J. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005, Dec; 64(6)|:490-3
  3. Kinaci A, Algra A, Heuts S, O’Donnell D, van der Zwan A, van Doormaal T. Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review. World Neurosurg. 2018 Oct;118:368-376
  4. van Doormaal T, Kinaci A, van Thoor S, Redegeld S, Bergmann W, van der Zwan A.Usefulness of Sealants for Dural Closure: Evaluation in an In Vitro Model. Oper Neurosurg (Hagerstown). 2018 Oct 1;15(4):425-432.

Polyganics Opens New State-of-the-Art Facility to Drive Growth

Groningen, The Netherlands, 20 April 2021 – Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announces its move to a state-of-the art, purpose-built facility on the Zernike Campus, Groningen. The new building will house Polyganics’ research laboratories, manufacturing and packaging facilities, and its offices.

The expansion is essential to accommodate Polyganics’ growing workforce and enable the Company to respond to the increasing demand for its commercial and pipeline products. This includes its own portfolios in PNR (Peripheral Nerve Repair), and Neurosurgery, with LIQOSEAL® gaining commercial traction in Europe, as well as the Stryker-owned NASOPORE® portfolio for ENT (Ear, Nose and Throat) surgery. In the near future, it will also include Polyganics’ new Liver and Pancreas sealant patch, ACTISEAL®, which is currently in clinical trials with first patients treated in Q3 2020.

Polyganics is committed to quality, safety, and sustainability in the development, manufacturing and commercialization of its medical devices, and the Company is determined to operate responsibly to improve environmental sustainability. These values have guided the design and construction of its new facility. Numerous measures have been taken to reduce and optimise energy use, minimize the use of water and enhance safety. For example, more than 600 solar panels have been installed, providing a renewable, clean energy source.

Rudy Mareel, CEO of Polyganics, said: We are happy to be moving into our new facility on schedule, just one year after we broke ground. The new building provides increased manufacturing capacity and space for up to 140 employees, to enable us to meet growing demand. Our lab facilities will be doubled in size, and our manufacturing facilities tripled. We are also delighted to be remaining in Groningen, with our established network of local partners and access to a high-quality talent pool. We look forward to joining the vibrant Zernike Campus, with the further collaborative opportunities this will afford.”

Jan Disbergen, COO of Polyganics added: “On behalf of the Company, I would like to thank the partners that have supported the development of our new facility and helped kickstart the next phase in Polyganics’ evolution. Particular thanks go to the City and the Province of Groningen which awarded us a RIG subsidy. The new building has further increased our focus on the environment and the health and safety of our employees. I would also like to extend my personal thanks to the construction, installation and equipment companies that have played an integral role in this journey.”

Edward van der Meer, Director of Campus Groningen, remarked: “We warmly welcome Polyganics to Campus Groningen, known as Northern Netherland’s Capital of innovation. Polyganics encompasses the collaborative spirit that resides here, where entrepreneurs, researchers and clinicians unite to pursue groundbreaking projects that have a tangible social and economic impact locally and worldwide. With a history of excellence in polymers, Groningen is a fitting home for industry leader, Polyganics and we are confident the Company will bring tremendous value to the campus.”

– ENDS –

For more information please contact:

 

Polyganics
Paul Roos, Chief Financial Officer
Marleen Schoonen, Director Corporate Communication & Corporate Affairs
T: +31 50 588 65 88
E: p.roos@polyganics.com | m.schoonen@polyganics.com

Instinctif Partners
Melanie Toyne-Sewell / Dr Katie Duffell
T: +44 (0)20 7457 2020
E: polyganics@instinctif.com

Notes to editors

About Polyganics

Polyganics is a medical technology company with multiple versatile polymer platforms. The company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.

Polyganics’ portfolio comprises of products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. The portfolio includes marketed products in the fields of Peripheral Nerve Repair (PNR) and Neurosurgery: VIVOSORB®, for minimizing unwanted tissue adhesions after surgery; NEUROLAC®, for supporting PNR following hand surgery; NEUROCAP®, for the management of symptomatic neuromas; and LIQOSEAL®, a dura sealant patch for the effective control of cerebrospinal fluid leakage. Products in development include ACTISEAL®, a Liver and Pancreas Sealant Patch in the field of General Surgery.

In 2014, Polyganics sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE® and NASOPORE-FD®) to Stryker, one of the world’s leading medical technology companies. Polyganics continues to manufacture the NASOPORE® product range for Stryker.

Polyganics is a privately held company based in Groningen, The Netherlands. The Company is ISO 13485-certified and its products have received clearance from the US FDA, CE-approval, and approval from the CFDA and other international authorities. Polyganics’ polymer platform technologies are protected by a broad portfolio of patents.

For more information, visit: www.polyganics.com, or follow us on LinkedIn: Polyganics BV