Sr. Engineer II, Project Lead
A Sr. Engineer II, Project Lead 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. This position is remote.
This position will lead the execution of medical devices and packaging development projects. The candidate is considered to be a device development subject matter expert (SME), and will provide project and engineering leadership in prefilled syringes and autoinjectors.
location: Chicago, Illinois
job type: Contract
salary: $30.21 - 43.16 per hour
work hours: 8am to 5pm
- The Project Lead will lead partner selection by assessing them via objective criteria and make a recommendation for the company pipeline.
- Area of focus will be to develop a platform device to implement the use of a reusable autoinjector.
- The device will need to be patient-centric, safe, reliable and include connected care aspects.
- Utilizes effective and efficient project management tools and best practices to deliver project goals.
- Identifies applications of functional knowledge and existing methodologies to lead teams to solve complex problems; provides advice on a wide range of issues within area of subject matter expertise.
- Communicates difficult concepts and negotiates with others to adopt a different point of view; Presents supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders in a way that persuades them to adopt a different point of view, when appropriate.
- Bachelor's Degree in Engineering + 10-12 years of direct experience or Master's degree with 8 - 10 years of direct experience (advanced degree preferred).
- Experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly.
- Experience with electromechanical components & systems.
- Experience with software development is optional but desirable.
- Knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements).
- Experience developing combination product devices from Development to Regulatory filings.
- Experience level: Experienced
- Education: Bachelors
- Medical Device
- Project Management
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.