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
- Bachelor's degree in an engineering or science field required.
- 5-7 years’ experiencerequired, 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 supportrequired for regulatory submissions.
- Demonstrated competence in product development processes and its application to ultrasound design.
- Microsoft Word, Excel, Power Point, Outlook, Project, Visio
- Excellent organizational skills and ability to plan/prioritize activities.
- Strong verbal and written communication skills; ability to present issues, plans and objectives.
- Ability to work in fast-paced organization, meeting multiple deadlines and succeeding under pressure is a must.
- Motivated, resourceful, ambitious, enthusiastic and attentive to detail.
Work From Home: NoTravel Percentage: Up to 25%