Commercial
Education, Business Experience And Physical Requirements
- Bachelor’s degree in a related field (e.g., life sciences, business, healthcare management).
- 1-2 years of operating room and clinical medical experience preferred.
- 80% travel required.
- Ability to work independently and collaboratively in a fast-paced, high travel environment to support the sales team.
- 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.
- Excellent communication and interpersonal skills.
- Strong problem-solving abilities and attention to detail.
- Ability to manage schedule effectively including high travel.
- Ability to conduct oneself professionally under pressure in evaluations.
- Identify and communicate opportunities for improvement and innovation.
- Strong public speaking skills to effectively lead training for staff, surgeons, and C-suite.
- Efficient with high-tech medical technology, including familiarity with standard business software platforms.
Description Of Responsibilities
- Independently guide and assist surgeons in the operating room by providing clinical and technical support of Envisio surgical procedures.
- Exhibit strong business acumen to provide customers with accurate product information, clinical data, and marketing resources that drive the adoption of surgical navigation solutions at identified institutions.
- Ensure that customers’ expectations are met or exceeded by consistently delivering exceptional customer service.
- Demonstrate comprehensive knowledge of surgical navigation technology, related products, and surgical procedures.
- Share key customer, procedural and market insight with sales and marketing to improve solutions and support sales growth for the organization.
- Collaborate with Area Directors and Surgical Account Managers to respond to physician needs, address customer requests, and build/close purchase orders.
- Assist Area Directors with launching evaluations and Surgical Account Manager team with launching 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.
- Establish, cultivate, and maintain strong relationships with key customers, clinicians, and decision makers at institutions identified by Director of Sales.
- 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 throughout their defined region.
Key Result Areas
The Clinical Sales representative is the clinical expert of the system during cases to guide staff and surgeons on how to properly use Elucent equipment. The Clinical Sales representative will be responsible for collaborating with the Area Director team and Surgical Account Manager team to drive corporate sales goals. Individuals must possess the ability to train new users on the technology while fostering strong client relationships to drive adoption of the surgical platform. Individuals must be able to conduct themselves professionally and work well under pressure throughout corporate IDN evaluations. The Clinical Sales representative will actively pursue new business opportunities through collaboration with Area Directors, under the direction of the Director of Sales.
Education, Business Experience And Physical Requirements
- Bachelor’s degree
- Five years of Medical Device Experience and/or business-to-business sales experience required
- Capable of standing for multiple hours at a time
- Capable of lifting up to 50 pounds on occasion or experience required
Required Competencies
- Demonstrated evidence of success in previous medical device sales role, indicating a high level of sales performance, influence and selling skills
- Capital Equipment experience
- Experience in the breast and/or lung cancer market
- Experience introducing new products into the market
- Ability to travel up to 75%
Description Of Responsibilities
- The Area Director is responsible for achieving capital sales goals and business objectives within their assigned territory
- Responsible for identifying and targeting new accounts to expand customer base by building champions with potential influencers, engaging with key stakeholders and driving the sales process
- Develop business plans to achieve annual sales quota associated with capital equipment and revenue numbers
- Develop key relationships with new and existing customers to build clinical champions through frequent visits, sales demonstrations, and educational opportunities
- Provide in-case procedural support for evaluations with prospective hospitals/physicians
- Provide in-case procedural support for existing customers when needed
- Regularly serve as a technical consultant to physicians in the procedure room, during live cases.
- Other key responsibilities include:
- Launching/installing/implementing new accounts
- Communicating pricing
- Building and delivering budgetary proposals
- Following up on contracts
- Management of all aspects of key customer groups, which may include members of large hospital systems/IDNs/GPOs, teaching, city and community hospitals.
- Maintain an active and ongoing commitment to compliance with all company policies and applicable federal, state and local laws, including but not limited to HIPPA, Sunshine Act and the Elucent Guidelines on interaction with US Healthcare Professionals.
Key Result Areas
- Quota attainment
- Overall compliance
- Team collaboration and ability to work with others
Education, Business Experience And Physical Requirements
- Bachelor’s degree
- Five years of Medical Device Experience and/or business-to-business sales experience required
- Capable of standing for multiple hours at a time
- Capable of lifting up to 50 pounds on occasion or experience required
Required Competencies
- Demonstrated evidence of success in previous medical device sales role, indicating a high level of sales performance, influence and selling skills
- Capital Equipment experience
- Experience in the breast and/or lung cancer market
- Experience introducing new products into the market ability to travel up to 75%
Description Of Responsibilities
- The Area Director is responsible for achieving capital sales goals and business objectives within their assigned territory
- Responsible for identifying and targeting new accounts to expand customer base by building champions with potential influencers, engaging with key stakeholders and driving the sales process
- Develop business plans to achieve annual sales quota associated with capital equipment and revenue numbers
- Develop key relationships with new and existing customers to build clinical champions through frequent visits, sales demonstrations, and educational opportunities
- Provide in-case procedural support for evaluations with prospective hospitals/physicians
- Provide in-case procedural support for existing customers when needed
- Regularly serve as a technical consultant to physicians in the procedure room, during live cases.
- Other key responsibilities include:
- Launching/installing/implementing new accounts
- Communicating pricing
- Building and delivering budgetary proposals
- Following up on contracts
- Management of all aspects of key customer groups, which may include members of large hospital systems/IDNs/GPOs, teaching, city and community hospitals.
- Maintain an active and ongoing commitment to compliance with all company policies and applicable federal, state and local laws, including but not limited to HIPPA, Sunshine Act and the Elucent Guidelines on interaction with US Healthcare Professionals.
Key Result Areas
- Quota attainment
- Overall compliance
- Team collaboration and ability to work with others
Marketing
Education, Business Experience And Physical Requirements
- Must currently be pursuing a degree in Marketing, Business, Communications, or a related field.
- Experience with social media platforms and content creation.
Required Competencies
- Strong organizational skills with attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and collaboratively within a team.
Description Of Responsibilities
- Manage Upload/Profiles of Prospective Leads from Tradeshows: Organize and manage the upload of prospective lead profiles from tradeshows into the CRM system. Maintain accurate and up-to-date records.
- Organize Physical Inventory: Maintain and organize the physical inventory of marketing materials, ensuring that supplies are stocked and readily available for events and campaigns.
- Organize Marketing Digital Inventory: Manage and organize digital marketing assets, including images, videos, and documents, ensuring they are easily accessible for the Marketing Department.
Key Result Areas
- Case Report Formatting: Assist in the creation and formatting of detailed case reports, ensuring accuracy and compliance with company standards.
- Direct Marketing to Tradeshow Leads: Develop with Area Directors a direct marketing campaign targeting leads generated from tradeshows to their region.
- Assist with Marketing Communications for Social Content Creation: Collaborate with the social media manager to brainstorm, create, and schedule engaging social media content that aligns with our brand voice and marketing goals.
Benefits of Marketing Internship
- Gain hands-on experience in various marketing functions.
- Opportunity to work in a dynamic and innovative medical technology company.
- Mentorship and guidance from experienced marketing professionals.
- Networking opportunities within the industry.
- Potential for future career opportunities with Elucent Medical.
Regulatory and Quality
Education, Business Experience And Physical Requirements
- Minimum 5 years experience as a Quality and/or Manufacturing Engineer
- Minimum 2 years in a quality function
- Electromechanical product experience with demonstrated evidence of product/process improvements required
- BA/BS degree in engineering or applied science (math, physics)
- Small/startup company experience preferred
- Experience working with contract manufacturers of single use products strongly preferred
- Experience working in 21 CFR Part 820, ISO 9001/13485, AS9100 or equivalent regulated environment required
- Demonstrated skills in statistical analysis
- Strong computer skills
- Individual must have a hands-on approach
- Strong organizational and time management skills
- Experience with complaint/post-market surveillance investigations, manufacturing quality support and risk management
- CQE preferred
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
- Direct management of Quality Engineers and Quality Technicians
Communication
- Excellent verbal and written communication skills a must. Experience or ability to engage with internal and external customers with demonstrated confidence
- 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 Engineering Manager is responsible for the administration and ownership of the elements of the quality system related to product quality. The responsibilities include reviewing and analyzing complaint and non-conforming material report data, performing and reviewing root-cause-investigations to establish corrective action plans and implementation of 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. The Quality Engineering Manager is also responsible for providing direct supervision and leadership to Quality Engineers and Technicians. Performs other functions as required.
Key Result Areas
Post Market Surveillance:
- The Quality Engineering Manager owns the Complaint Process, leads Complaint Investigation Team as needed and is responsible for ensuring root cause determination and ultimate resolution of product failures. Will work closely with Development and Operations and other functional areas to evaluate actual or potential product failures and update risk documents as necessary
- Contributes to product safety, product quality, and customer satisfaction related decisions (both data based and risk-assessment-based decisions)
- Leads or participates and supports internal and external supplier audits and inspections
- Monitors and advises on how the product quality is performing and publishes data and reports regarding the effectiveness of the quality management system in achieving the product performance goals
Product Acceptance and Investigations
- Owns the Non-Conforming Materials process
- Plans and conducts the analysis, inspection, design, tests, and/or integration of test methods to assure the quality of assigned products or components
- Develops test methods and participates in the assessment of returned products, incoming, in-process and final test/inspection
- Coordinates the documentation review, inspection workflow, training, problem solving and calibration for products and test equipment
- Tracks and report quality metrics
- Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality
- Utilizes statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits
- Manages the non-conformance reporting system, driving timely disposition and closure. Leads and/or participates in MRB meetings, identifies non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems
Product Development and Operations
- Contributes to the development and implementation of product test plans including Verification and Validation of products and processes
- Serves as liaison to design, procurement and manufacturing engineering
- Participates as a resource in validations applicable to processes and product
- Performs standard quality engineering reviews of design documentation for compliance with requirements
- May lead cross function teams in planning, analyses (dFMEA, FTA, Risk/Benefit) and mitigations
- Works with Manufacturing Engineering to address supplier quality issues
Education, Business Experience And Physical Requirements
- HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2 yr degree.
- Knowledge and experience with electronics manufacturing preferred
- Good math and technical skills
- Excellent computer skills including MS Office
- Knowledge of quality systems including use of electronic quality management systems software preferred.
Required Competencies
| Leadership/Personal Conduct:
· Maintains positive attitude when working with peers, customers or suppliers. · Comfortable working in a self-directed team environment and giving or asking for instructions. · Demonstrate an understanding of the medical industry. · Works effectively on cross functional teams to establish appropriate processes pertaining to quality. · Individual must have a hands-on approach. · Strong organizational and time management skills. Communication · Excellent written and oral communication skills. · Positive and cooperative communications and collaboration with all levels of employees, customers, contractors and suppliers. · Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions. |
Description Of Responsibilities
The Quality Technician performs materials and product assessment testing in support of medical device development and manufacturing in compliance with GMP. The individual is responsible for receiving and in-process inspections, material release in support of medical device manufacturing. The Quality Technician may be called upon for reviewing and approving job travelers (DHRs) prior to product release.
In addition, the Quality Technician will support administration of quality systems within the electronic quality management system, as assigned. In this role, the position works cross functionally with process stakeholders to ensure quality system processes are documented appropriately and are completed within the expected timeframes.
Other duties may be assigned
Key Result Areas
Development/Manufacturing Support:
- Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.
- Responsible for receiving inspection activities including, but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
- Responsible for performing in-process and final component, sub-assembly and product inspection.
- Document non-conformance reports once parts fail specification or requirements.
- Performs and/or supports troubleshooting, investigations and problem solving of issues and non-conformances.
- Assures quality systems documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions.
- Demonstrates safe work habits, maintains clean and safe work area.
- Completes all other duties as assigned by supervisor.
Quality Systems:
- Develop and write quality systems procedures as requested by supervisor.
- Provides support during customer audits.
- Supports supervisor in preparation of Management Review.
Research and Development
Education, Business Experience And Physical Requirements
- Required: bachelor’s degree in Math, Physics, Computer Science, Engineering, or related field
- Experience with data acquisition in a laboratory environment
Required Competencies
- Strong knowledge of data collection and good laboratory practices (following instructions, highlighting issues, and documenting results)
- General knowledge of mechanical, electrical, and software fundamentals
- Excellent documentation and communication skills
- Detail-orientated with a focus on delivering high-quality results
Description Of Responsibilities
The General Tester at Elucent Medical works closely with the electrical, mechanical, software, and test engineers to evaluate prototype software and hardware, execute test plans, and record observations to assist in the development of cutting-edge surgical localization systems. The ideal candidate for this role will possess a strong aptitude for troubleshooting, curiosity about medical technology, and eagerness to learn. This candidate should be able to collaborate and communicate effectively with others, follow instructions with general direction, and ensure compliance with company policies.
Key Result Areas
- Work closely with electrical, mechanical, software, and test engineers to evaluate prototypes, execute test plans, and record observations
- Ensure compliance with company policies and procedures
- Collaborate effectively with others to achieve project targets and objectives