Will build clinical and administrative champions, as well as the ability to identify, qualify, and cultivate new opportunities through the entire capital sales process. Will effectively master the clinical, technical, and industry knowledge needed to cultivate and develop surgeon support and engagement, as well as the ability to effectively communicate the clinical, financial, and market development aspects behind the technology/program to the executive team, in order to drive capital sales and meet quarterly and annual sales quotas.
· Ownership of all capital sales initiatives within the assigned geography to meet or exceed quota.
· Identify, qualify, and cultivate new opportunities through targeting key surgeons, markets, hospitals, ASC’s, developing clinical champions, executing upon the capital sales process through the entire cycle.
· Create, manage, and grow the capital sales pipeline through targeting, cold-calling, networking with surgeons, executives, industry peers, and leads generated by the company.
· Effectively present the clinical benefits and the clinical aspects of the technology to prospective surgeons, put clinical validation steps in place, execute upon them, and open up executive discussions around the technology and robotics program.
· Assist in managing key aspects of the clinical validation steps, including peer to peer discussions, robotic demonstrations, Case Site Visits, Robotic Roadshows, Cadaver Labs, etc.
· Effectively present the clinical, financial, and market development opportunities behind the technology and program to key hospital and ASC executives in order to secure the program and partnership, on an off-budget timeline.
· Work with the hospital CFO/Finance Team to tailor the acquisition model that will allow them to capitalize on the technology in an off-budget timeline.
· Assists potential customers in building their business plans, including hospital-specific market data, competitive market analysis, Return on Investment, and any additional aspects needed to help the customer justify the acquisition of the technology.
· Develop and assist with market development activities geared towards educating surgeons, patients, and hospital executives on the technology, as well as stimulating the market.
· Detailed organization and reporting of all key status updates and milestones of the capital pipeline to leadership, via sales reporting tools and processes, pipeline update calls, etc.
· Leads the launch of new robotic programs, including pre-launch activities with key hospital stakeholders and Memic team members, coordination and execution of the launch meeting, introduction of the Memic launch team, and effective hand-off of the program overall to the Memic clinical and marketing teams.
· When needed, participates and supports key industry meetings, marketing events, clinical events, etc.
· Bachelor’s degree with a minimum of 5 years demonstrated success in Medical Capital Sales; combination of education and experience is acceptable.
· Executive selling experience background. (CEO/CFO/COO of hospitals)
· Ability to travel up to 75%
· Excellent communication, both written and verbal, required.
· Prior experience using CRM
· Valid Driver’s license
Clinical Trial Manager
USA | Clinical Affairs
Under the direction of the VP, Clinical Affairs, the Clinical Trial Manager will assist in the development and maintenance of the necessary clinical documents to support clinical studies, provide training to study team, coordinate, manage and oversee the various aspects of clinical studies.
● Assist in development and maintenance of necessary clinical documents (e.g., protocols, design data collection forms, patient consent forms etc.)
● Identify qualified study sites
● Regulatory submissions to IRBs and FDA
● Communicate directly with contracted research organizations (CROs) - Set targets for clinical monitoring team per project goals, oversee and ensure proper monitoring conduct
● Oversee and guide clinical research associates (CRA) and clinical data managers (CDM)
● Coordinating site management activities (training, procedures, technical issues, monitoring)
● Train appropriate clinical research personnel and MEMIC relevant employee on the conduct and requirements of the regulated clinical study
● Support and monitor clinical sites to ensure protocol compliance and data integrity
● Generate study specific work activity reports, and other materials and documents needed for the efficient execution of clinical studies
● Gathering and examining study documents.
● Safety reporting
● Oversee study payments (CRO, site payments etc.)
● Regulatory folder management and maintenance (responsible for the correct filing and archiving of clinical study documents, and the maintenance of study files)
● Collaboration with the IL clinical team
● Complete customer complaints
● Oversee study conduct, and communicating study status to the VP of clinical Affairs on an ongoing basis
● Assuring compliance with CFR and local laws
● Write summaries, presentations, and other supplementary materials for investigator and internal team meetings
● Present clinical data at sales meetings, surgeon meetings and industry conferences
Education and Necessary Skills
● A minimum of a bachelor's degree in life science, Biomedical engineering or closely related field with 5 years of professional experience.
● A minimum of 3 years as a clinical trial manager in the medical device industry
● Excellent organization skills and ability to focus on detail
● Ability to work independently and communicate well with other colleagues
● Outstanding communication skills, both verbal and written
● Time management skills
● The confidence to present protocols or training sessions to colleagues and site staff
● Proficient with Microsoft Office Word and Excel
● Valid driver's license and US Passport required
● Ability to travel 50% domestically and internationally
Mobile Showroom Demonstration Specialist
USA | Customer Services
The Mobile Showroom Demonstration Specialist fills a pivotal role in support of the Memic Sales and Clinical Services team by 87000ensuring safe and timely transportation of the mobile demonstration lab. The MSDS will be responsible for maintaining the mobile showroom lab inventory as well as maintain proper service records for the vehicle. The MSDS is a technical and clinical expert on the Hominis® system and will assist with surgeon demonstrations, lab sessions, and troubleshooting on an as needed basis. With the provided exposure to training and product demonstrations this position will facilitate movement to other opportunities within the company.
· Safely transport the mobile showroom lab to and from sites around Eastern US.
· Support and assist the sales team in the set-up, demonstration and break-down of the Hominis® system.
· Coordinate closely and effectively with the sales team and marketing team to meet all showroom deadlines and appointments and any marketing related activities such as attendance at Tradeshows.
· Possess a current and expert level knowledge of the Hominis® system as well as relevant anatomy and procedures.
· Coordinate with destinations to secure demonstration location for showroom lab.
· Ensure proper inventory levels of all clinical equipment as well as ensure all equipment is maintained prior to any demonstration.
· As necessary, work with the clinical and technical services team to provide remote troubleshooting and maintenance assistance.
· Maintains a positive, friendly, and helpful demeanor, and will represent Memic in a professional manner.
· Own setup and teardown for clinical demonstrations and lab sessions and provide support during these events as needed.
· Schedule and document proper maintenance records for the assigned vehicle.
· Always ensure cleanliness and functionality of the mobile lab.
· Maintain a clean driving record and obtain all relevant traffic and safety laws.
· Bachelor’s degree with a minimum of one (1) year prior medical device experience; or an equivalent combination of education and experience.
· Knowledge of the medical device surgical robotics industry required; gynecology preferred.
· Current and valid driver’s license with clean driving record required.
· Ability to travel up to 75% and to independently manage travel logistics and to work nights and weekends as needed.
· Excellent verbal and written communication skills
· Problem solver who can maintain composure and identify solutions in a high-pressure environment.
· Ability to effectively work in an evolving start-up environment where job demands can shift on a regular basis.
· Self-starter who performs well with autonomy and can be flexible in a dynamic work environment.
· Evidence of positive and trustworthy relationship-building through all levels of an organization.
· Ability to lift up to 50 lbs.
USA | Sales & Marketing
We are expanding our Software Team and seeking a Software Engineering Leader for managing and leading U.S Software Engineering team in the effective design, implementation, and operation of Memic software products and services.
• Accountable for the design and development of effective software that meets given complex, strategic business needs.
• Recruit, mentor, and manage an effective software engineering team
• Ensure alignment of the team products and services with Memic technology and architecture strategy
• Provide technical knowledge and insight to peers and colleagues
• Lead the software architecture design, implementation, documentation, testing, and product release.
• Recruit, mentor and manage an effective software engineering team. Provides ongoing coaching and support for the overall success and of the team.
• Provide technical knowledge and insight to peers and colleagues and facilitate knowledge sharing.
• Practice test-driven development methodologies to achieve the highest code coverage possible for unit-testing
• Ensure the team’s approach to testing is fit for purpose
• Ensure integration of the software with monitoring and support tools
• Review and give constructive feedback on others’ code
• Support product and departmental managers in communicating strategy and product fit and effectiveness to stakeholders at all levels
• Ensure the team’s software works well in its operating environment
• Ensure that the team’s technical product documentation is always complete, accurate, and coherent.
• Ensure troubleshooting and resolution of issues throughout the product life cycle including out of hours support for incident resolution.
• Work with other technical leaders in the broader organization to define, document and distribute best practice and standards.
• Define, lead and encourage continuous improvement of the team delivery and development processes.
• Work with project, product leads to design software and create implementable specifications and tasks at product and roadmap level.
• Work with subcontractors where necessary providing direction, support and documentation.
• Learn new technologies and keep abreast of existing technologies and help introduce them where appropriate.
• Responsible for team’s products archival and release.
• Participate and oversight of software risk assessments.
• Plan and monitor work plans, coordinate, develop, document, and maintain robust and extensible software.
· Bachelors’ degree in Computer Science or Engineering with a minimum of 7 years hands-on software development experience (C++/C#)
· Minimum of 2 years’ experience managing and developing a team of Software Engineers or Developers
· 5+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
· Fluent in real-time systems and object-oriented languages, Cloud advantage
· Experience in motion control and Robotics Advantage
· Expertise with real time SW and communication protocols
· Demonstrated applied expertise in FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, IEC 62366, and IEC 62304
· Experience in working in an environment following Agile methodology – advantage
· Demonstrated applied expertise with Software FMEA process
· Experience leading nearshore and/or offshore development partners
· Familiarity with health and data privacy regulations
· Ability to travel domestically and internationally 10%.
· Valid US Passport
Technical Service Quality Engineering Intern
USA | QA
Energetic and passionate Technical Service / Quality Engineer with an entrepreneurial spirit and strong technical writing and communication skills who will support Quality activities of the Technical Services Engineering team. Support process in compliance with ISO 13485 and FDA 21 CFR 820 Quality Systems Regulation. Work with Technical Services and Quality Assurance teams to implement and support processes.
· Work with SMEs to author and edit Quality Management System (QMS) processes as required
· Participate in Feedback process (field service reports, clinical case reports, customer satisfaction surveys, etc.) and ensure proper documentation.
· Support the documentation and review of service work orders (Service Records, Customer feedback tickets, etc.) and activities for QA compliance and disposition.
· Ensure proper handling & closure of support and commercialization related CAPAs incl. task tracking, root-cause analysis, and completion of documentation.
· Support and provide input to continuous improvement process resulting from lessons learned.
· Travel to and participate in service calls, installations, and cadaver labs as necessary to maintain practical field service process knowledge.
· Ensure Service tooling is calibrated and maintained in accordance with SOPs.
· Support achievement of quality objectives and requirements by working with the cross-functional team
· Assist with the implementation, validation, and maintenance of software systems, including but not limited to: Service Management Software (SMS), Customer Relationship Management (CRM), Complaint, Training, etc.
· Support documentation of logbooks as needed for Quality Records, such as Feedback, Complaints, CAPAs, Training, etc.
· Support external audits through back-room documentation retrieval and SME prep, or front room scribe duties.
· Facilitate and support quality and engineering in the investigation and resolution of complaints.
· Support maintenance of training records for Employees and Customers
· Support overall cross-functional compliance to Good Documentation Practices (GDP) & Good Manufacturing Practices (GMP).
• Bachelor’s degree or equivalent in an engineering field, or current enrollment in a Bachelor’s of Engineering program.
• Experience in the medical device industry an asset.
• Familiarity with ISO 13485 and FDA 21 CFR 820
• Strong technical writing and communication skills
• Strong organizational and project management skills
• An appreciation for the documentation supporting successful process execution
Indications for use: The Anovo™ Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Anovo™ Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Anovo™ Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo™ Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy • Total Benign Hysterectomy with Salpingectomy • Total Benign Hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal. Caution: The safety and effectiveness of the Anovo™ Surgical System was established only for the representative uses mentioned in the Indications for Use. The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying is ease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon. The prescription-use symbol or “Caution: Federal law restricts this device to sale by or on the order of a physician.” For safety information, including risks, indications, and specific warnings and cautions related to the Anovo™ System please refer to the Anovo™ Surgical System Instructions for Use provided with your Anovo™ Surgical System.