Immediate need in Deerfield IL for a Principal Engineer. Engineer will be responsible for developing new products used in surgical procedures, through partnerships with R&D and other cross functional team members. strong understanding of Quality compliance i.e. building quality into products through design control and compliance with procedures. Engineer should be able to navigate with sustaining the products in the field in compliance with the quality system and technical expertise and have had hands on experience with product development and risk management activities.
- BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
- At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
- Extensive medical device design controls experience.
- Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence
location: Deerfield, Illinois
job type: Contract
salary: $40 - 50 per hour
work hours: 8am to 4pm
- Ensure compliance to procedures, especially Design Control and Risk Management with respect to development of new products. Active participant in the Core Team, applying engineering knowledge to move projects forward successfully.
- Ensure compliance to Change Control procedures to make changes to currently marketed product.
- Act independently as QA R&D product SME with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on science & technical knowledge.
- Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
- Manage routine small projects without assistance. Coordinates with cross functional team to set realistic timelines and set team for success.
- Recommend design improvements via customer feedback investigation and analysis.
- Experience level: Experienced
- Minimum 8 years of experience
- Education: Bachelors
- Product Development
- Risk Remediation
- Design Control
- CAPA TW8
- Medical Device
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.