Vacancy expired!
Please note that this is a long term contract position.
In addition to what is outlined in the JD:
• Technically minded and able to understand the digital component of the role (digital hardware and software)
• Able to work in a new ambiguous space
• Not necessarily medical device experience, but need to understand the process and have knowledge of medical device principles
• Someone that has prior GMP pharma industry experience- not someone from a machine shop
Summary
• We are seeking an experienced individual to join a project development team within our Global
Clinical Supply organization. This person will be responsible for supporting development and
implementation of digital low voltage IoT technologies for integration with drug product
packaging and supply for use in clinical trials. This includes new innovative solutions which
include electronic paper displays and screens (e-paper, e-Ink), smart digital medication
adherence monitoring packaging, and digital cold chain technologies. This person will work as
part of multi-disciplinary teams including process engineers, IT, operations, and regulatory.
• They will bring expertise in medical device development and low-power microcontroller systems
to support the team in ensuring the products we develop and implement are consistent with
requirements and specifications
• Experience specifically with Medical Device development and Electronic Paper Displays (e-Ink) is
preferred, but not required
Responsibilities
• Develop requirements and specifications for use of low power electronic products (using RFID,
NFC communication protocols) and verify design performance
• Collaborate closely with our manufacturing partners to qualify/validate products through
various methods of engineering support, testing, and analysis throughout the produce lifecycle
• Create and execute test plans to ensure internal specifications, industry standards, design
controls and regulatory compliance are met
• Performs functional hazard assessments and Failure Modes and Effects Analysis for the analog
and digital systems
• Evaluate emerging technologies and develop concepts for future product designs to meet
requirements
Qualifications
• Bachelors, Master's or Doctorate of Science degree with an engineering discipline, preferably in
Biomedical Engineering, Electrical Engineering, or equivalent with a minimum of 10+ years
professional experience
• Curiosity and aptitude in problem solving for in-depth technical exploration
• Creativity in designing experiments and the ability to clearly explain their ideas and outcomes
• Ability to become the expert on new technology platforms for education and demonstration
• Excellent organizational skills and attention to detail with regard to planning logistics of pilot
builds, scheduling testing and following-through on execution and data analysis
• Proven ability to effectively communicate advanced technical theories/concepts in written and
verbal formats for technical and nontechnical audiences
• Strong interpersonal, collaborative, and negotiation skills to reach consensus, alignment, and
commitment
• Experience with design, manufacturing, verification, design controls, and risk management
associated with medical devices and digital hardware
• Understanding of Failure Modes and Effects Analysis for digital systems and reliability
engineering
• Understanding of electronics including schematics, semiconductor, and engineering system
design; including experience with digital and analog circuitry
• Familiar with test methods for characterizing microelectronics performance and robustness
• Familiar with the use of application software and associated hardware relating to PCB layout,
microprocessor hardware and firmware development
Applicants must provide their phone number. Reference job number A2082.
