Sr Clinical Engineer
About The Position
The Ottava team envisions a future for robotic intervention that is targeted, minimally invasive, and personalized. Building upon a deep understanding of patient and physician needs, we are developing a platform for the next evolution of soft-tissue robotic care! We are a team of clinical, electrical, mechanical, mechatronics, robotic controls, and software engineers who are passionate about improving patient care. The team includes a wide range of experience levels from junior engineers to industry experts. We value autonomy and empower each other to take action while remaining a supportive and closely knit team. We take pride in our culture and are committed to building an environment that is inclusive and promotes diversity of thought through varied experiences and backgrounds. As a member of the Clinical Engineering team, you will join us on our journey to design and build a First-Of-Its-Kind Table-Integrated Robotic System. With a unique architecture, clinically differentiated instruments, and backed by an open digital ecosystem, we are looking for a high impact, user-centric clinical engineer to join our team to expand our instrument portfolio. You will have the opportunity to understand user needs, establish clinical and engineering requirements and design inputs, consider clinical risks, solve technical problems in clinical settings and identify solutions to guide product development. This role offers high autonomy and growth opportunities within the team as we progress towards realizing our vision. If you enjoy being in the forefront of product development working alongside with clinicians and engineers, we love to hear from you.
Requirements
- Hold a bachelor's degree in engineering (e.g. Biomedical, Mechanical) with a minimum of 5 years of related work experience in medical device industry (Master’s + 4 years of experience or PhD + 2 years of experience)
- Experience collaborating with physicians to gather clinical performance feedback and identify unmet needs
- Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams such as R&D, product management, human factors, professional education etc.
- Experience designing and conducting pre-clinical engineering studies to assess product performance and safety
- Proficient in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliability
- Experience developing Design Validation strategy, protocol creation and testing
- Experience constructing customer and engineering design requirements
- Ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources
Nice To Haves
- Advanced degree (Masters, PhD, MD)
- Knowledge of laparoscopic procedures and operating room workflow
- Familiar with fundamental concepts in surgical robotics
- Prior device or instrument design experiences
- Proficient in statistical methods and programming languages such as MatLab, Python is a plus
- Big data
- Strong knowledge of relevant regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards.
- Demonstrated success in leading and delivering complex projects from inception to completion.
- Have the ability to travel up to 15% of the time, internationally and domestic
Responsibilities
- Apply in-depth clinical, technical, and design control knowledge to collaborate with a cross-functional team to discover, define, develop, and validate a new product
- Partner with physicians and key clinical users to develop and characterize device performance, gather product feedback, and integrate their insights into product iterations
- Discover unmet clinical needs, establish customer requirements and provide clinical input to engineering design requirements
- Apply clinical knowledge and advanced data analysis technique to develop bench models and metrics for evaluation of prototypes designs to ensure clinical performance needs are met and maintained during development
- Develop new product clinical workflows, conduct clinical risk assessments, and propose effective mitigations for identified hazards
- Collaborate with pre-clinical and regulatory teams to support and advance pre-clinical studies
- Write plans, protocols, conduct formal testing, and report results of Design validation studies throughout the design process as required by FDA regulations
- Support developing customer training materials, user manuals, labeling, formative and summative assessments
- Support initial product launch and initial cases during customer site bring up
Benefits
- Inclusive work environment
- Respect for diversity and dignity of employees
- Recognition of employee merit
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What This Job Offers
Job Type
Full-time
Career Level
Senior
