Future Opportunities: Clinical Engineering Team

Future Opportunity Posting:

Even if our current openings don't perfectly align with your skill set in Clinical Engineering, we're still eager to connect. Your expertise and passion are valuable assets, and we believe there may be opportunities to collaborate or explore tailored roles that leverage your talents. By sharing this detailed job description and offering a glimpse into our vibrant company culture, we're on the lookout for top talent who share our passion for transforming the healthcare landscape. If you're driven by the prospect of leveraging pioneering medical technology to positively impact patient care and are open to exploring future opportunities, we encourage you to reach out and discover the endless possibilities of joining our dynamic team.

About The Team:

Our Clinical Engineering Team works closely with cross-functional development teams to represent clinical value propositions for patients and providers throughout the design and development of new products. You will be responsible for owning and delivering specific Product Development Plan (PDP) deliverables throughout the project's lifecycle. Our Clinical Engineering Team is a collaborative force, working hand-in-hand with cross-functional development teams. We champion the voice of the physician throughout the entire product lifecycle, ensuring new products deliver significant clinical value. You'll play a key role in translating user needs into actionable plans by partnering with the Product Manager and angaging with phycisians. You'll also be instrumental in designing and running studies to assess the design's adequacy during development. This includes defining clinical performance metrics, leading pre-clinical evaluations of new features and changes, spearheading design validation activities, and maintain crucial risk considerations.

A Day In The Life on our Clinical Engineer Team:

• Develop internal expertise in clinical domains relevant to the company's products

• Understand current state of end-user and patient environment

• Build knowledge about relevant anatomy and disease states

• Become aware of alternative and competing treatment modalities

• Remain current with the latest in scientific publications relevant to the company's products

• Attend key scientific conferences and engage with clinicians

• Lead and execute evaluation of new product and service prototypes

• Provide clinical perspective on product concepts

• Perform bench assessments of prototype clinical performance

• Understand clinical needs identified by development team

• Understand and champion clinical value propositions defined by development team

• Develop new test methods, models, and metrics for quantifying product performance.

• Own and manage in-house preclinical testing facilities

• Manage regulatory compliance processes for the preclinical testing facilities.

• Lead development and execution of new protocols for assessing product characteristics in various tissue-based models.

• Own and deliver specific Clinical Engineering team deliverables throughout the project's lifecycle

• Develop clinical hazards analysis and documentation to inform product design

• Document existing procedure workflow and develop new product workflows throughout development process

• Provide input to development teams to define and validate clinical performance goals for products

• Develop customer training materials, user manuals, labeling, and other supporting materials

• Assist in development of plans and materials for company engagement with the FDA and other regulatory bodies.

• Write plans, protocols, conduct formal testing, and report results of preclinical, formative, summative, and validation studies throughout the design process

• Support initial product launch by developing customer training activities, supporting initial cases during customer site bring up, and conducting Physician Preference Testing.

About You:

• Experience in a medical devices industry

• Bachelor's degree in Engineering or Science; Master's degree preferred

• Strong technical experience and aptitude

• Ability to effectively communicate concepts, ideas, and knowledge to other individuals and teams.

• Knowledge of basic anatomy, clinical terminology, and general surgical techniques.

• Knowledge of fundamentals of robotics or electromechanical systems.

• Experience in gathering customer feedback, generating user requirements, and conducting validation studies on medical devices

• Experience in the regulated medical device environment, including but not limited to document control processes, design control processes, protocol development, and report writing.

• Experience working with healthcare providers in a hospital environment

• Experience conducting Design Validation and Human Factors / Usability testing for FDA submissions.

• Ability to travel domestically up to 25% of the time.

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

• Competitive Salary

• Comprehensive health insurance including Medical, Dental and Vision+ HSA and FSA options

• Equity & Bonus Program

• Life Insurance (company paid & supplemental) and Disability insurance

• Mental health support through medical insurance programs

• Legal and Pet Insurance

• 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days

• Paid parental leave

• In-office snacks and beverages

• In-office lunch stipend

• Learning & Development Opportunities: On-demand online training and book reimbursement

• Team building and company organized social and celebration events