Commercial
Education, Business Experience And Physical Requirements
- Bachelor’s Degree in related fields preferred.
- Experience managing others preferred.
- 3-5 years experience within the healthcare arena strongly preferred.
- 5+ years in clinical environment and/or medical device industry preferred.
- Prior experience as a Clinical Applications Specialist or similar role strongly preferred.
- Prior experience building a training/education curriculum for a medical device organization
Required Competencies
- Must be willing to travel up to 30% of the time.
- Organized, self-motivated, excellent verbal and written communication skills, and detail oriented.
- Proficient in the use of PC software applications including Microsoft office.
Description Of Responsibilities
- Manage, guide and oversee tasks of Domestic Sales Trainers on clinical training-related matters.
- Mentor and assist all newly hired field representatives and international distributors in achieving expert level of product knowledge, support techniques and medical acumen in relevant areas of expertise.
- Create and perform on-site and in-house assessments for new hires in order to assess clinical competency.
- Create best practice webinars for current field representatives in order to discuss training-related matters.
- Create training quizzes for current field representatives in order to assess understanding of training-related matters.
- Maintain Learning Management System for current employees.
- Create material on learning management system including, but not limited to, Litmos, PowerPoint presentations, quick reference guides, video clips and quizzes for new hires, current employees and international distributors.
- Provide guidance and training to domestic and international prospective clients, physicians and other medical personnel by evaluating options and problem solving during medical procedures using company products and services.
- Contribute to quality assurance and improvement processes by recommending product modifications as needed.
- Maintain appropriate knowledge of developments, products and services in the required medical fields.
- Assist as needed with field service requests including, but not limited to, procedure support, installations, evaluations and training.
Key Result Areas
- Serve as the key clinical training point person and liaison to the Sales, Marketing, and Clinical teams regarding training related issues.
- Develop and implement in-house training programs for all new hires, as well as manage onboarding and new hire’s day-to-day training between in-house programs including, but not limited to, case observations, online training, etc.
Education, Business Experience And Physical Requirements
- Bachelor’s degree in a related field (e.g., life sciences, business, healthcare management).
- Proven track record in 2-3 years business-to-business sales.
- Operating room and medical sales experience preferred.
- A deep understanding of surgical navigation technology and its applications.
- Ability to work independently and collaboratively in a fast-paced, high travel environment to drive sales.
- Willingness to travel as needed to meet with clients and attend industry events.
- Individual is occasionally required to sit; climb or balance, and stoop, kneel, crouch, or crawl. Will need to stand during procedures for elongated periods of time. Frequently lift and/or move up to 25lbs. Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Required Competencies
- Self- starter.
- Solutions driven mindset to surpass quota.
- Excellent communication and interpersonal skills.
- Strong problem-solving abilities and attention to detail.
- Ability to manage schedule effectively including high travel.
- Identify and communicate opportunities for improvement and innovation.
- Efficient with high-tech medical technology, including familiarity with standard business software platforms.
Description Of Responsibilities
- Increase utilization of Elucent platform within hospitals and ambulatory surgery centers to meet or exceed sales quota in assigned territory.
- Demonstrate comprehensive knowledge of surgical navigation technology, related products, and surgical procedures.
- Exhibit strong business acumen to provide customers with accurate product information, clinical data, and business reviews that drive the adoption of surgical navigation solutions.
- Establish, cultivate, and maintain strong relationships with key customers, clinicians, decision makers, and key institutions.
- Expand business through training radiologists, surgeons, and staff on the Elucent platform.
- Build a robust referral network, KOL team, and Center of Excellence program within territory.
- Launch accounts post sale through providing education, training, and case support to allow the site to become successfully independent with continued support from their Surgical Account Manager.
- Provide ongoing product training and in servicing of platform with physicians, nurses, technicians, and navigators.
- Collaborate with Area Directors to identify referrals at other facilities that would benefit from Elucent Medical’s technology.
- Ensure that customers’ expectations are met or exceeded by consistently delivering exceptional customer service and support.
- Work in partnership with the Director of Sales to develop and implement territory business plans designed to achieve sales quota in territory.
- Complete all assigned continuous education learning modules and business logistics training courses (Salesforce, SLACK, Aquity MD, Reimbursement/ROI calculator). Utilize these tools to grow sales in respective territories.
Key Result Areas
The Surgical Account Manager will be responsible for exceeding revenue goals by clinically driving the adoption and utilization of navigation technology in surgical procedures. Individuals must possess the ability to foster strong client relationships to expand Elucent Medical’s market presence within facilities. Individuals will actively pursue new business opportunities through physician referrals, oncology program development, and collaboration with Area Directors.
Regulatory and Quality
Education, Business Experience And Physical Requirements
- Minimum 3 years experience as a Quality Engineer in the medical device industry
- BA/BS degree in science, engineering or technical field
- Medical device quality management systems including 21 CFR Part 820 (QSR) and ISO 13485 (or aerospace AS9100)
- Demonstrated skills in statistical analysis
- Strong computer skills
- Individual must have a hands-on approach
- Strong organizational and time management skills
- Electromechanical device/system experience required
- Experience with nonconforming material investigations, manufacturing quality support, and risk management
Required Competencies
Leadership:
· Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers · Capable of leading a product investigation team and/or working with internal and external customers to resolve product quality issues · Works effectively on cross functional teams to establish appropriate processes pertaining to quality Communication · Excellent written and oral communication skills · Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies · Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations |
Description Of Responsibilities
The Quality Engineer is responsible for reviewing and analyzing nonconforming product data, performing root-cause-investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR) and ISO 13485. Performs other functions as required.
Key Result Areas
Nonconforming Materials
- Provide leadership for the nonconforming material process.
- Identify nonconformance trends. Develop and administer technical investigation and corrective action programs to resolve recurring quality problems.
- Focus on NCMR cycle time, ensuring timely completion of actions related to nonconforming materials.
- Implement standardized rework practices where appropriate to reduce potential production delays related to nonconformances identified in-process.
Internal and External Quality Performance
- Track and report quality metrics.
- Plan and conduct the analysis of internal production performance, including potential opportunities to streamline the production process.
- Contribute to product safety, product quality, and customer satisfaction related decisions (both data based and risk-assessment-based decisions).
- Gather data related to supplier performance and work with suppliers to provide a consistently high level of quality and service.
- Participate in and support internal and external supplier audits and inspections.
Product Development
- Participate in validation and verification activities related to product development.
- Provide leadership and input into risk analysis activities related to product development.
Research and Development
Education, Business Experience And Physical Requirements
- BS in Mechanical Engineering or Biomedical Engineering.
- 7+ years development experience; at least 3 in the medical device field.
- Proven experience developing medical device products from concept to commercialization.
- Strong technical problem solving skills.
- Expertise designing in SolidWorks or a similar CAD program for 3D modeling.
- Expertise in generating engineering drawings.
- Excellent verbal and written communication skills.
- Strong track record of cross-functional collaboration.
- Focus on organization and detail.
Required Competencies
- Extensive background in designing components for a variety of manufacturing methods, including injection molding, machining, sheet metal fabrication, welding, adhesive assembly, etc.
- Extensive prototyping experience with methods including 3D printing, hand tooling, CNC machining, etc.
- Experience designing for integration with electrical components.
- Experience in performing risk analysis / FMEA.
- Experience creating and maintaining vendor relationships.
- Experience working within a Quality Management System, preferably Grand Avenue Software.
- Familiarity with customer and product requirement generation.
- Familiarity with verification test method development and execution.
Description Of Responsibilities
The Senior Mechanical Engineer will be responsible for developing new products and sustaining existing technologies within the EnVisio and SmartClip product lines as well as new treatment areas.
The role will include a mix of responsibilities, with a majority being new product development and a minority involving sustaining engineering. This includes design, analysis, prototyping, testing, troubleshooting, reviewing, and documenting for both single-use devices and capital hardware.
The EnVisio technology is a multidisciplinary system, and as such, cross-functional collaboration will be critical to success.
This is a full-time, on-site role.