Digital Device Integration Engineer at Biogen in Cambridge, MA

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Job Description

Biogen is seeking a qualified candidate for the role of Creating and Implementing, innovative solutions in the Medical Device & Packaging team. The position will lead the novel technology area of disease monitoring, adherence and compliance within devices and packaging, with patient centric focus, aligned to the drug pipeline, as well as execute deliverables with internal stakeholders and external partners for Biogen, for the device products in Biogen's portfolio.

This role bridges the enterprise operation of end-to-end discovery through regulated clinical trial and clinical outcome focus in the neuroscience portfolio at Biogen. The successful candidate will have industry experience and evidence of innovation applying novel technologies in the measurement outputs and patient centric adherence and compliance solutions.

Responsibilities:

1. Leads PO&T interaction with the DQM (Digital Quantitative Medicine), MERI (Medical Evidence Research & Innovation) and relevant organizations, within Biogen.
2. Project efforts across PO&T, as is the department of regulatory level device industrialization and the R&D / Worldwide Medical organization
3. SME in the engineering design process integrating a variety of technology, device and packaging applications that solve the data production and acquisition challenge of measuring motor action and motor planning, physiological, cognitive and speech and language measures.
4. Lead efforts in device and packaging adherence and compliance solutions
5. Create and evaluate mechanical/electromechanical concepts/prototypes with user unmet needs and relevant technology
6. Optimize design concepts to improve performance for usability and design robustness
7. Test systems on bench top models, during design verification and human subjects testing
8. Analyze designs for function, assembly, manufacturability, etc. using both CAE and Engineering techniques related to Design For Six Sigma
9. Liaise with third parties such as specialist manufacturers
10. Evaluate external device and packaging landscape for innovative and implementable solutions for disease monitoring, adherence and compliance
11. Create and develop Intellectual Property in design and utility device and packaging space
11. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers
12. Ensure all designs function as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.

#LI-SK2

Qualifications

  • 8+ years' experience in medical device design, electromechanical and sensor technology, tooling, assembly and production controls for assembly.
  • Deep understanding new product introduction, design and development of device products with digital context.
  • Deep knowledge of the regulatory and compliance requirements of device design controls and combination products. ( i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements)
  • Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device, packaging vendor base
  • Strong understanding and application of validation processes (IQ/OQ/PQ) in product device manufacturing.
  • Experience developing multiple device and packaging products from research through registration and launch.
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
  • Comfortable working in a matrix environment, while embracing and driving change

Master's Degree in Mechanical or Electromechanical Engineering required, PhD preferred- and 8 years' plus experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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