Our Client, is a growing cardiopulmonary therapeutics company that is developing a unique technology to make inhaled nitric oxide (NO) from air. Inhaled NO is an effective tool, but tanks are not widely accessible for treating pulmonary hypertension worldwide. The tank-less product will offer a disruptive solution which will allow us easy entry to both US and Global markets. The product will be so simple to use that babies who currently lack access to this medicine will soon be treated; saving lives in emerging markets.
We are looking for an experienced Clinical Engineer who is passionate about building products that customers love. Come join our dynamic and fast paced environment and working with our cross-functional teams to design, build and roll-out our new world changing products.
- Act as an advocate for the users needs both internally and with key external partners.
- Interact with clinicians and Key Opinion Leaders (KOL) in clinical environment.
- Work with users to gain clinical knowledge and drive user-centric product requirements to ensure successful integration of product with existing clinical workflows in a real-world environment.
- Define clinical testing protocols, execute user studies and analyze user feedback and clinical input to drive development of product and clinical experience that meets user needs.
- Identify clinical risks, track clinical feedback, generate reports and tie information into usability documents, e.g. UFMEA (User Failure Mode Effects Analysis), use cases, and other relevant human factors usability eengineering documentation.
- Establish partnerships with clinical and non-clinical stakeholders, work closely with engineering teams and build positive professional relationship.
- Collaborate with quality and regulatory partners to support regulatory submissions.
- MS/BS degree in biosciences, engineering, respiratory therapist, nursing or equivalent discipline
- Must have at least 3+ years of experience in biotechnology, pharmaceutical or medical device industries
- Must have ICU, hospital or medical devices experience
- Good knowledge of IEC 62366
- Work experience in Human Factors Engineering/Human Factors Validation
- Proven work experience throughout the product life of a combined hardware & software medical device.
- Solid clinical background with understanding of human physiology, the clinical workflow and applied technologies in hospital critical care.
- Skilled at working effectively with cross functional teams in a matrix organization.
- Exceptional interpersonal and communication skills to build relationships internally and externally, with our users, corporate sponsors and with clinicians
- Ability to produce and present clear, concise, and professionally written communications, graphics, and presentations.
- Traveling 15-30% of the time domestically and/or abroad required
Nice to have
- 3+ years of experience in preclinical setting or regulated medical device development (executing preclinical studies, first in human studies and IDE studies experience are a plus)
- Experience with and/or knowledge of FDA submission and approval processes preferred
- Experience User Interaction/User Experience design
Our Client provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
The job summary, responsibilities and requirements listed above are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the responsibilities and skills required of this position. Reasonable accommodations may be made for any part of the application or interview process, and to enable qualified individuals with a medical condition or disability to perform the essential functions.