Medical Device Testing Specialist

1 month ago

Deeside, Flintshire, United Kingdom ConvaTec Full time

About the Role:

We are seeking a highly skilled Medical Device Testing Specialist to join our team at ConvaTec. As a key member of our R&D team, you will be responsible for designing, planning, and executing physical testing in support of new product development and existing product development of medical devices.

Key Responsibilities:

  • Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures.
  • Design, plan, and execute physical testing in support of R&D and SEG activities and base business projects in accordance with applicable procedures and guidelines.
  • Involvement in the development and validation of new physical testing methods.
  • Effective organization of assigned workload; ensures the integrity of all data generated and timely/accurate provision of results to GLP standards.
  • Accurate recording and analysis of laboratory data in accordance with good documentation practices.
  • Perform detailed laboratory investigations to determine the root cause of atypical and out-of-specification results, apply corrective and preventative actions, and author concise investigation reports.
  • Author validation protocols, reports, and technical documents for Medical Devices/Pharmaceutical products.
  • Assist in laboratory test method/procedural revisions.
  • Responsible for standard laboratory routines, equipment calibration, maintenance replenishment, etc.
  • Ensures lab compliance with applicable cGMP regulations and SOPs/TDs.
  • Involvement in change control activities and associated actions.

Requirements:

  • Bachelor's Degree in a relevant science-related discipline.
  • Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
  • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
  • Good working knowledge of Microsoft Office, specifically Word and Excel.
  • A detailed understanding of common statistical analysis and experience with MiniTab is desirable.

About You:

  • Have an understanding of the role of Physical Testing within the product development process for both new product development and existing product development of medical devices/pharmaceuticals.
  • Commands good physical testing and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of physical testing tasks to support key R&D projects.
  • Statically analyze data for reporting to senior physical testing staff.
  • Effectively communicate both oral and written scientific and technical data to peers and managers.
  • A thorough knowledge and understanding of the principles and concepts of compliance management, GMP/GLP, and good documentation practices.
  • Competent in the production of high-quality, accurate R&D technical documentation in a timely manner.
  • A forward-thinking team-player who willingly accepts new challenges and works to tight deadlines.
  • Commands flexibility - ability to prioritize, manage multiple tasks, and react/respond positively to changes in priority and workload.
  • Accurate with excellent attention to detail.
  • Decisive thinker: ability to make decisions and recommendations using own initiative.

Working Conditions:

  • Working in a laboratory environment with exposure to biological agents, chemicals, and reagents.
  • Competent in the disposal of chemicals and reagents in accordance with site and environmental procedures - Training will be provided.

Travel Requirements:

There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.

At ConvaTec, we are committed to providing a work environment that is inclusive, diverse, and rewarding. We believe that our employees are our greatest asset and are dedicated to supporting their growth and development. If you are a motivated and talented individual who is passionate about making a difference in the lives of others, we encourage you to apply for this exciting opportunity.

  • Medical Device Development Specialist

    6 days ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job OverviewConvaTec is seeking a highly skilled Medical Device Development Specialist to join our team. As a key member of our R&D department, you will be responsible for designing, developing, and testing medical devices that meet the highest standards of quality and safety.Key ResponsibilitiesDevelop and implement design control processes to ensure...

  • Laboratory Technician

    4 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job SummaryConvaTec is seeking a skilled Laboratory Technician to join our team in a medical devices environment. As a Laboratory Technician, you will be responsible for testing and releasing third-party products and raw materials, ensuring compliance with Good Laboratory Practices (GLP) and regulatory requirements.Key ResponsibilitiesPerform routine...

  • Senior Medical Device Validation Engineer

    7 days ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Company Overview:Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.About Us:We are a leading provider of advanced wound care, ostomy care, continence...

  • R&D Engineer

    4 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the RoleWe are seeking a highly skilled Development Engineer to join our team at ConvaTec, a global medical products and technologies company. As a key member of our team, you will play a crucial role in the design and development of customer-focused sterile and non-sterile medical devices.Key ResponsibilitiesDesign and develop medical devices from...

  • Regulatory Affairs Specialist

    1 month ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the RoleThe Regulatory Affairs Specialist will drive improvements in regulatory affairs processes, systems, and infrastructure while supporting regulatory strategy and registration across global markets and the Regulatory Affairs group.Key ResponsibilitiesDevelop and execute regulatory strategies for phased launches of newly developed products, changed...

  • R&D Development Engineer

    3 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job DescriptionPioneering innovative medical solutions to enhance patient care is at the core of our mission at ConvaTec. We are seeking a highly skilled R&D Development Engineer to join our team, focusing on the development and manufacturing of customer-centric sterile and non-sterile medical devices.Key Responsibilities:Design and Development: Design and...

  • Lead Technical Project Manager – Medical Devices

    3 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job Title: Technical Project Manager – Medical DevicesAbout the Role:As a Technical Project Manager at ConvaTec, you will play a vital role in delivering new medical solutions that improve patient outcomes. You will oversee the planning, execution, and tracking of key operations projects, ensuring they meet agreed-upon deliverables, timelines, and...

  • Medical Laboratory Professional

    2 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About ConvaTecWe are a global medical products and technologies company, committed to providing innovative solutions for the management of chronic conditions.With a strong presence in over 100 countries, we strive to improve the lives of those we touch through our advanced wound care, ostomy care, continence care, and infusion care products.Salary &...

  • Medical Solutions Specialist

    6 hours ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Company Overview:Convatec is a global leader in medical products and technologies, dedicated to improving the lives of people worldwide. Our commitment to innovation and quality drives us to develop cutting-edge solutions for chronic condition management.Salary:$85,000 - $110,000 per year, depending on experience.Job Description:This role involves working...

  • Analytical Laboratory Specialist

    1 week ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    We are guided by our five core values, which shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What's Right.Job DescriptionThis position supports the release process for all raw materials, intermediates and finished product testing, and supports the testing program for externally manufactured products.The...

  • Innovative Medical Device Designer

    2 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About ConvatecConvatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. With around 10,000 colleagues, we provide our products and services in almost 100 countries.We are pioneers in trusted medical solutions to improve the lives we touch. Our revenues in 2023 were over $2 billion. The...

  • Project Manager for Medical Devices Operations

    1 week ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About Convatec:Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. With leading positions in advanced wound care, ostomy care, continence care, and infusion care, we provide our products and services in almost 100 countries.We are united by a promise to be forever caring. Our...

  • Laboratory Technician

    4 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job OverviewAs a Laboratory Technician at ConvaTec, you will play a vital role in supporting the release process for all raw materials, intermediates, and finished product testing. This position requires a strong knowledge of good laboratory practices (GLP) and the ability to work efficiently to daily testing routines and turnaround deadlines.Key...

  • Lead Technical Project Manager – Medical Devices

    4 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the Role:We are seeking a skilled Technical Project Manager to join our team at ConvaTec, a global medical products and technologies company. As a Technical Project Manager, you will be responsible for overseeing the planning, execution, and tracking of key, complex operations projects, ensuring they adhere to agreed-upon deliverables, timelines, and...

  • Packaging Development Engineer

    2 days ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job Description:Packaging plays a critical role in the success of medical devices. As a Senior Packaging Specialist at ConvaTec, you will be responsible for developing technical packaging specifications and leading/supporting best design packaging initiatives.You will work closely with the Convatec Sourcing and Marketing teams, packaging suppliers, packaging...

  • Scientific Researcher II

    1 month ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    ConvaTec Job DescriptionWe are seeking a highly skilled Scientific Researcher II to join our team at ConvaTec, a global medical products and technologies company. As a key member of our R&D team, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.Key Responsibilities:Perform stability testing...

  • R&D Development Engineer

    1 month ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the RoleConvaTec is seeking a highly skilled R&D Development Engineer to join our team. As a key member of our development team, you will be responsible for designing and developing customer-focused sterile and non-sterile medical devices across multiple locations.Key ResponsibilitiesDesign and develop medical devices from concept through to...

  • Technical Project Director for Advanced Medical Solutions

    1 week ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the RoleWe are seeking an exceptional Technical Project Director to lead our advanced medical solutions project pipeline. This is a fantastic opportunity for a highly skilled and experienced professional to join our team and drive cross-functional project execution.Key ResponsibilitiesCollaborate with the New Product Delivery Lead to provide leadership...

  • Scientific Researcher I

    3 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    Job Summary: We are seeking a skilled Stability Scientist I to join our team at ConvaTec. This role will involve working within a controlled ISO13485 and ISO9001 Laboratory quality system, designing and executing physical testing in support of R&D and SEG activities, and ensuring the integrity of all data generated.Key Responsibilities:Design, plan, and...

  • Regulatory Affairs Strategist

    2 weeks ago

    Deeside, Flintshire, United Kingdom ConvaTec Full time

    About the RoleConvaTec is a global medical products and technologies company, focused on solutions for the management of chronic conditions.Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to drive improvements in regulatory affairs processes, systems, and infrastructure while supporting regulatory strategy and registration across...