Here are the current positions available with ivWatch. To apply for any position, use the form below.
The Software Engineer works in a cross-functional team environment on all phases of software development including requirements, documentation, feasibility, risk analysis, estimation, design, implementation, unit testing, support of verification/validation, and maintenance of commercialized product. This person will have an active role in a business that makes a difference in improving patient care. The individual must be a team oriented, self-directed learner with a strong desire to positively impact the industry, our customers, and to drive company growth.
- Leads in the design and implementation of reliable and high quality embedded software targeted to ivWatch medical devices
- Leads design documentation and plans efforts, including detailed software design documents, software development plans and software configuration plans
- Leads software requirements definition with other members of the software team as appropriate (team lead, architect, etc.) and proactively works to integrate with system requirements
- Participates in software project risk assessment including estimates of impact on time, budget, and scope
- Collaborates with other members of the software team to execute code and design reviews of devices
- Leads in working with Clinical Research team to store and manage data acquired during clinical studies
- Drafts and maintains software documentation for FDA submission
- Drives the software risk analysis process
- Participates in issue resolution and communication across discipline teams in order to deliver software projects on-time and on-budget
- Estimates software engineering tasks and provides input to project schedules
- Investigates and corrects software defects found during verification/validation and in the commercialized product
- Ensures adherence to established project management methodologies, regulatory requirements, and best practices.
- Advances the exciting culture of a young medical device company
- Bachelor’s degree in Computer Science, or equivalent discipline
- Minimum of 5 years of Medical Device product development experience
- Demonstrated experience in software C++ development lifecycle, object oriented design methodology and programming languages including one of the following: C or JavaDesign experience of software for hardware instruments
- Experience with medical device regulatory standards (e.g. FDA QSR, ISO)
- Working knowledge of object-oriented design and development
- Working knowledge of Structured Query Language (SQL) and relational databases
- Experience in software documentation for FDA submissions
- Experience with software configuration tools
- Solid organizational and multi-tasking skills
- Strong written and verbal communication skills
- Ability to work well in cross-functional team environment
Inside Sales Representative
The Inside Sales Representative is responsible for achieving sales revenue projections and targets within the territory by sourcing new sales opportunities through inbound lead follow-up and outbound cold calls and emails. Incumbent will continuously update the CRM system with all activities, communications and planned activities.
- Document all activities, communications, and planned activities in company’s CRM system. Keep CRM system current on a regular basis
- Develop and expand existing and new sales opportunities through inbound lead follow-up and outbound cold calls and emails
- Route qualified opportunities to the appropriate Area Directors for further development and closure
- Assist in development of sales forecasts for assigned territory through analysis and interpretation of general economics, industry, marketing and sales data to assist with operational planning, inventories, pricing and budgetary requirements
- Effectively manage initial sales process in territory to help meet or exceed territory sales goals
- Meet routinely with VP of Sales with regard to account progress, growth and coverage, call patterns, competitive strategies and market opportunities, including weekly pipeline sales calls
- Investigate warranty claims and complaints, and expedite required services to assure customers’ satisfaction.
- Support evaluation program within territory.
- Ensure customer needs are met or exceeded.
- Work independently and adapt to a changing environment.
- Keep abreast of the latest developments related to the product and market.
- Perform all administrative tasks required of the position.
- Work additional hours as necessary to meet objectives.
- Bachelor degree in business, economics, any life science or engineering related field.
- Five or more years of B2B medical sales experience.
- Good working knowledge of CRM system and Microsoft Office Suite.
- FDA approved medical devices industry experience preferred.
- Solid judgment along with decision making skills.
- Ability to juggle multiple assignments and work on tight deadlines.
- Exceptional communications and follow-up skills.
Digital Media Specialist
The digital media specialist will be responsible for creating and managing digital-related projects for the organization to establish a web presence to boost brand awareness. Duties include organizing, maintaining and updating digital resources for media campaigns and presenting progress and initiatives to department directors
- Create marketing or promotional content for social media outlets and digital media distribution
- Update website and social media accounts with relevant articles, videos and blogs
- Maintain a consistent corporate voice throughout all communications
- Monitor and manage content including blogs, message boards, discussion groups, live chats, and status updates
- Edit and filter inappropriate content and thoughtfully respond to inquiries or complaints that arise from blog or social media correspondence
- Manage end-to- end digital projects
- Experience with knowledge of software such as Photoshop, Illustrator, Dreamweaver, Flash and/or InDesign, Final Cut Pro, Premier Pro, Audacity or other media editing software
- Basic knowledge of HTML or CSS for the creation of websites or additional web pages a plus
- Experience with visual communication principles
- SEO experience – Google Analytics and Google Adwords
- Coordinate with Marketing, Sales and Product development teams to ensure brand consistency
- Excellent analytical and project management skills
- An ability to multitask and perform under tight deadlines
- Strong verbal and written communication skills
- Provide feedback and analysis to management and other business functions
- Bachelor’s degree in media design, digital media, or a similar field
- Stay on top of current design trends as well
- Additional qualification in web design or animation is a plus
- Familiarity with web design and content management systems
The Clinical Educator will coordinate activities and training for product evaluations and product implementation at hospital sites. The position requires traveling to hospital sites and educating nurses and staff on the proper use of ivWatch medical devices. This position will require the incumbent to continuously monitor and update all required training, immunizations and documentation to be allowed on premise at customer sites.
- Train hospital staff at evaluation sites on proper use and operation of the assigned products
- Monitor initial use of the devices at the customers’ sites to establish the safe and proper use of the ivWatch medical device products
- Maintain responsibility for successful execution of evaluation trials at customers’ sites
- Complete all required training, immunizations and documentation to be allowed to educate hospital staff on premise
- Travels as necessary in performance of duties
- Works additional hours as necessary to meet objectives
- Bachelor’s degree in a related field (e.g. nursing, physical sciences, communications) is preferred
- Understanding of hospital protocols
- Must be energetic, willing to work long hours and travel extensively
- Good working knowledge of Microsoft Office Suite
Director of Quality Management
The Director of Quality Management is responsible for effectively leading, implementing, maintaining and ensuring compliance of the company’s quality system and for reporting on the performance of the Quality System to executive management. This position is also responsible for assuring that all national and international regulatory requirements are attained including facility registrations, Quality System Regulations and any other applicable requirements.
The Director of Quality Management duties include but are not limited to the following:
- Manage the Quality Management department
- Write, implement and maintain Quality and Regulatory procedures and processes that meet FDA, ISO, MDD, CMDR, JPAL and other medical device requirements.
- Serves as the custodian for all such quality-related documentation. Works with other departments to establish and maintain appropriate standards, guidelines and quality criteria.
- Lead and manage FDA inspections and notified body audits.
- Maintain product design history files, risk management files and technical files.
- Responsible for MDR and Vigilance reporting, product licensing/registrations, establishment registrations and other regulatory or compliance activities.
- Lead team to facilitate and support management reviews, internal audits, complaint management, CAPA management, quality metrics, non-conformances and investigations of product quality issues.
- Serves as the Management Representative for ISO 13485 quality system requirements.
- Communicate and collaborate with suppliers regarding quality requirements, quality procedures and product non-conformances.
- Prepares periodic reports, trend analyses, memoranda, and other communication for and on the behalf of top management.
- Bachelors of Science Degree with preference in Engineering or one of the Life Sciences.
- Minimum of 7 years experience in a medical device industry.
- Minimum of 5 years in a role implementing and maintaining a Quality Management System.
- Minimum of 3 years experience leading teams.
- Knowledge of FDA Quality System Regulations, ISO 13485, European Medical Device Directive, Canadian Medical Device Regulations, the Japanese Pharmaceutical Law requirements and other international requirements as the company grows.
- Strong writing skills for creating documentation for the quality management system and
- Knowledge of ISO 14971, IEC 60601, ISO 10993, ISO 11135 and IEC 62304.
- Ability to work with technical departments to ensure strong regulatory compliance.
- Excellent working knowledge of Microsoft Office Suite (Word and Excel) and product life cycle management solutions.
- Professional communication skills and willingness to solve problems collaboratively.
- Exceptional interpersonal and relationship building skills, team-oriented and strong leadership and decision-making skills.
- Excellent organizational skills, with superb attention to detail.
- Ability to take initiative and provide appropriate follow-up.
- Ability to handle and complete a variety of projects simultaneously.
- Ability to prioritize projects for the quality and regulatory team and manage time to complete multiple projects with established timelines and goals in a fast-paced environment.
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