A Senior III Digital Device Integration Engineer is needed for a multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide in the Cambridge, MA area. Client is seeking a qualified candidate for the role of Senior III digital device integration engineer in the Device Design and Process Development group.
location: Cambridge, Massachusetts
job type: Contract
salary: $80.00 - 86.33 per hour
work hours: 8am to 5pm
- Create and evaluate mechanical/electromechanical/software concepts/prototypes with user unmet needs and relevant technology
- Optimize design concepts to improve performance for usability and design robustness
- Test systems on bench top models, during design verification and human subjects testing
- Analyze designs for function, assembly, manufacturability, etc. using both CAE and Engineering techniques related to Design For Six Sigma
- Liaise with third parties such as specialist design/development firm or device/packaging manufacturers
- Create and develop Intellectual Property in design and utility device and packaging space
- Communicate effectively, both verbally and in writing, internally across departments and with external suppliers
- Ensure all designs function as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.
- Master's Degree in Mechanical or Electrical Engineering required, PhD preferred
- 8+ years' experience in medical device design, electromechanical and sensor technology, wearables
- Deep understanding of design and development of device products with digital context.
- Deep knowledge of the regulatory and compliance requirements of combination product and digital device solution in US, EU and other regions
- Experience with SaMD, SiMD, wireless connectivity, cybersecurity
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device, packaging vendor base
- 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
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.