职位描述
Who we want
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices.
User-focused creators. Engineers who design with the user in mind, developing software that helps change patients’ lives.
What you will do
The Staff R&D Engineer is responsible for a wide variety of investigative research and new technology/platform development that advances the division’s capabilities and supports the long-term growth strategy. You will provide technical skills, leadership, innovative thinking, and customer focus, while engaging with other divisions and third parties to deliver new technologies and platforms.
Essential Duties and Responsibilities
- Works cross-functionally to execute new technology/platform development strategies that are aligned with the five-year strategic plan
- Approaches complex problems with an inquisitive nature—embraces multifaceted inputs to develop comprehensive & creative solutions
- Plans and leads new technology and platform execution from proof of concept to pilot scale and to market release as applicable
- Partners with Advanced Operations to facilitate the transfer of new technologies into design specifications and manufacturing processes
- Collaborates with our Sales and Marketing teams, as well as customers to better understand business and clinical needs, and translate those into value propositions for business investments
- Works with Advanced Quality to determine new technology/platform risks and mitigation strategies
- Supports the alignment of Regulatory and Marketing on product claims and launch strategies
- Researches and develops novel comprehensive test methods and systems to support diverse technologies and platforms
- Possesses proficiency with project management principles to effectively meet technology readiness objectives and other project milestones to achieve desired outcomes
- Provides leadership and mentorship for other engineers
- Plans and directs new product development including leading design team activity to perform root cause analysis and modify plans as appropriate
- Leads the development of technical protocols and reports to support technology readiness confidence levels and other project milestones
- Sponsors animal studies with test facility for clinical feedback as applicable
- Provides leadership in business updates/presentations to management and stakeholders
- Potential supervisory responsibilities of interns or R&D technicians for new technology/platform execution
What you need
- Bachelor's degree in an engineering or science field required.
- 5-7 years’ experience required, medical device industry preferred, or
- 3-5 years’ experience, medical device industry preferred, with Master’s degree in engineering or science field, or
- 1-3 years’ experience, medical device industry preferred, with PhD in engineering or science field.
- Advanced understanding of Statistical Methods and Project Management Principles (formal training preferred).
- Ability to direct development of an action plan and estimate requirements for resources – management, tasks, budgets, labor, materials, and time required to complete projects.
- In-depth knowledge of medical terminology/concepts related to medical devices.
- Advanced knowledge of FDA requirements associated with the development of medical devices including Design Control and the technical support required for regulatory submissions.
- Demonstrated competence in product development processes and its application to ultrasound design.
- Microsoft Word, Excel, Power Point, Outlook, Project, Visio