The Design Engineer performs design development, validation, and engineering activities; support R&D functions, interacts with CMO vendors and automation suppliers in specifying systems required for high volume manufacturing.
Essential Functions:
Manage teams of internal, external, and contract resources that design, deliver, validate and maintain manufacturing systems for a drug delivery medical device. Develop and maintain all aspects of Design History File working with internal and external vendors.
Develop methods for validation, product performance testing, environmental and shelf-life testing. Review new designs, enhancements, and programs with product developers and the formulation team to support a robust drug-device combination product.
Design and develop test fixtures for prototype testing, fixtures for early prototype assemblies. Create and manage Master Validation protocols in accordance with our quality system, compliance regulations, and industry best practices.
Manage budgets, project schedules, and report and resolve project issues. Lead cross-functional partnerships with department heads in R&D, operations, quality assurance, contract manufacturers, and other stakeholders to define project scope, estimates, and seek organizational alignment.
Deliver excellent customer service to stakeholders and internal customers, work with Quality Engineers and Regulatory Affairs to ensure device related documentation is maintained per relevant standards. Experience in developing URS for submitting to Assembly Automation vendors.
Education:
Bachelors Degree (BA/BS): Engineering Design, Medical device design or related - Required
Master Degree (MS/MA): Engineering Design, Medical device design or related - Preferred
Experience:
5 years or more in industry experience is required.
3 years or more in industry experience is required.
Skills:
Strong skills in GD&T, DFM/A & DHF documentation • Risk Assessment methodologies like Fault Tree Analysis, FMEA, Hazard Analysis etc. - Advanced
Proficient with Solidworks design software. • Strong skills in developing V&V methods and processes for Functional Test Systems. • Highly detail oriented in design, debug, and documentation work. - Advanced
Ability to plan work and accomplish objectives with minimum of direction. • Strong written and verbal English language communication skills. - Intermediate
Strong skills in creating and making technical presentations to small and large audiences. • Strong communication and organizational skills. • High attention to detail, personal initiative, and follow-through. - Intermediate
Specialized Knowledge:
5-8 years of previous Design or Quality experience preferred.
