Principal Design Quality Engineer
About The Position
We have an exciting opportunity to join the Design Quality team supporting the TheraSphere Y90 device. TheraSphere is a catheter-based, loco-regional radiation therapy approved for the treatment of liver cancer. In addition, it has received FDA Breakthrough Device designation for the treatment of glioblastoma, and the team is investigating safety and efficacy of the therapy for this cancer. This Principal Design Quality Engineer will work with high-performance cross-functional development teams to progress the Human Feasibility Assessment, and ultimately to the program's strategic, commercial goals while ensuring delivery of the highest quality product to the customer. In this role, you will make important contributions to exciting new applications and excel in a dynamic, fast-paced environment for product development.
Requirements
- Bachelor's degree in an Engineering discipline
- 9+ years of experience in design assurance, quality, or related medical device experience; or Master's degree and 7+ years experience.
- Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 13485 and ISO 14971 Quality Standards
- Proven use of Quality tools and methodologies
- Demonstrated problem-solving, critical thinking, and data analysis capabilities
- Hands-on approach to product development and qualification
- Ability to collaborate and influence across multiple, cross-functional teams
- Strong communication skills (verbal and written)
Nice To Haves
- Comfort with self-directed work in addition to collaboration in a team environment
- Experience with clinical trial support, multi-site teams, and contract manufacturers
- Self-starter with the ability to identify improvement opportunities
- Strong ability to successfully multi-task and adapt
- Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
Responsibilities
- Leads or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Design Change, and NCEP/CAPA/PIR
- Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
- Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors
- Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions
- Understand clinical use cases and user interface requirements to drive design decisions and implement through the risk management package.
- Participates as a division representative in cross-divisional projects defining the quality system and may advise management of potential improvements to the quality systems and processes
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Supports functional and divisional design quality goals and priorities
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
