Senior Biomedical Engineer

Senior Biomedical Engineer

Mallinckrodt Pharmaceuticals

Dublin, Ireland

Job Description:

The Senior Bio Engineer requires broad and deep experience with all types of complex electrical/mechanical equipment used as pharmaceutical delivery systems, complex drug injectables, as well as electrical/mechanical extracorporeal blood treatment systems - spanning all clinical application settings including: NICU, PICU, Adult ICU, Anesthesia, Acute Care, Home and Transport. This experience is used extensively for device validation and qualification efforts critical to the labeled drug(s) indication.

In addition, the Senior Bio Engineer role assists with research in the hospital and medical transport environment. The role also provides key information to product support representatives within Mallinckrodt which allows them to understand the complexities of the following in relation to the products: Hospital policy/procedure, Air carrier policy/procedure, Medical transport policy/procedure, & FAA rules and regulations regarding medical transport.

The Senior Bio Engineer plays a key role in creation and review of many SOP’s and design process documents and specifically will own the Human Factors/Usability Engineering SOPs, WIs and associated templates. These documents require intensive clinical and field input. The Senior Bio Engineer role leads the collaboration for these key documents, (labeling, instructions for use, validation strategy/protocols, validation reports, and other reference materials), by closely coordinating with the US/EU field-based Clinical Specialists, Technical Services team, engineering teams and others to establish consensus on the documents prior to approval. This individual will also work closely with Quality and Manufacturing to ensure that processes are in place for all design activities.

Job Responsibilities:

  • Technical understanding of how devices function in order to reproduce accurate clinical scenarios requires a specific understanding of cardio-pulmonary management.
  • Perform Validation of all ventilators interfacing with device delivery system(s).
  • Understand new innovative technologies within the industry that interface with the different therapies.
  • Support of technical content of Technical Bulletins, operators manuals and label copy.
  • Ensure that strategic proposal milestones and costs are achieved with cross functional partners
  • Direct leadership of validation and qualification campaigns including coordination of internal and external staff responsible for all validation/human factors development activities.
  • Create and manage design input (user needs) working collaboratively with Commercial, Service, Medical Affairs, Regulatory, Customer Care and other stakeholders.
  • Own particular CAPAs through the establishment of guidelines, operating principles, procedures and training curriculums.
  • Develop and maintain relationships assigned with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers.
  • Collaborate closely with functional areas such as Quality, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings.

Job Requirements:

  • 7-10+ years of clinical experience in Respiratory Therapy
  • 5+ year of validation of complex, software-driven, electromechanical medical device systems experience a plus
  • Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues

Leadership Characteristics: Making Complex Decisions

  • Complex problem solving and decision-making based upon the available data.
  • Leverages personal experience
  • Open and collaborative style

Communicating Effectively

  • Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across

Managing Diverse Relationships

  • Effective at building strong cross functional relationships with the key stakeholders
  • Communicates up and down appropriately and effectively
  • Ability to develop relationship and collaborate with external suppliers and Key Opinion Leaders

Acting with Integrity

  • Is a person of high character; is consistent and acts in line with a clear and visible set of values and beliefs; deals and talks straight; walks his/her talk; is direct and truthful but at the same time can keep confidences


  • BS/MS degree in in a scientific or engineering discipline, preferably Biomedical Engineering
  • Training/Certification in Human Factors Engineering/Usability Testing

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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