Device Design Assurance Engineer/Scientist (12
Mylan N.V.
Dublin,Leinster,IE
1d ago

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people.

If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Here's how this role will help :

  • Support Global Device Development (GDD) programs through the design and development lifecycle for Combination products and medical devices, by ensuring compliance to design control requirements outlined in the GDD Quality Management System, and relevant Regulations and International Standards.
  • Establish and maintain Design History File contents for development programs where GDD are the Design Authority, or in collaboration with development partners, and acquired programs;
  • this shall include associated activity plans and timelines

  • Support Risk Management activities for development programs through the implementation of EN ISO 14971 : 2012 / ISO 14971 : 2007
  • Support GDD in maintaining ISO 13485 : 2016 Quality Management System certification through involvement in Management Review, Internal Audits, CAPA, Complaints, while ensuring relevant Regulatory requirements are adhered to, e.
  • g. 21 CFR 820, Medical Device Directive (93 / 42 / EEC), Medical Device Regulation (2017 / 45).

  • Participate in external audits Global Corporate Auditing, Health Authority Audits, Certification Body audits.
  • Establish and rollout best practice training to GDD personnel and relevant Mylan Affiliate sites, to ensure compliance with GDD requirements and Mylan Global policies.
  • Maintain awareness of ongoing industry best practices, new QSRs and QMSs requirements as they are developed, and implement improvement actions for the GDD QMS
  • Support Health Authority submissions as required
  • Support general GDD activities as they arise
  • Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude.

    People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

    Here are the minimum qualifications and essential functions for this position :

  • Degree in Biomedical or Mechanical Engineering / Science or equivalent, with 5 to 7 years experience.
  • Direct experience of device development and manufacturing operations activities for device or drug / device systems in a GMP environment.
  • Experience of Technical Transfer of products and processes into a Commercial Manufacturing facility.
  • Proven track record in the application of risk management and associated tool / s (e.g. FMEA) within a device development environment
  • Solid understanding & implementation of ISO13485 & the MDD 93 / 42 / EEC, Annex 1 "Essential Requirements" with a working knowledge of the pharmaceutical outputs and associated regulatory requirements.
  • Experience in the implementation of device design controls and ISO / FDA requirements as applicable to device design.
  • Support the generation / understanding & maintenance of the DHF within a regulatory environment across multiple device programs.
  • Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established time lines.
  • Willingness to travel where necessary, including device development groups across the UK and Ireland, and Affiliate / Partner sites.
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