Commercial
Education, Business Experience And Physical Requirements
| Reports to: | Director of Sales Operations |
| EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS | |
| · 3+ Years
· Customer Service experience required · Medical Device/Industry experience · ERP/CRM experience · Startup, small business experience preferred |
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Required Competencies
Strong communication skills and ability to work effectively with others. Self-starter who has helped develop or improve customer service processes.
Description Of Responsibilities
The Customer Service Specialist will be primarily responsible for interfacing by phone and email with Elucent’s customers, such as: hospital administrators, nurses, and purchasing individuals as it relates to the sale and replenishment of our single use devices. The specialist will be responsible for aspects of the customer experience including receiving and processing customer orders, packaging, ensuring a timely shipment that meets the customer needs, as well as, collections in some cases.
The Customer Service Specialist will also be involved in proactive replenishment calls based upon cases performed. The specialist will analyze sales, case, and inventory data to help maximize sales and material availability.
The Customer Service Specialist will be responsible for providing both our customer and field sales team with support to ensure effectiveness of the field-based team members. The specialist will be a cornerstone role in the organization helping to interface field resources and internal resources to maximize operational excellence.
Key Result Areas
Customers
Assist in growing our customer base in fast scaling industry.
Maintain customer records and provide sales operations support to the field.
Proactively reach out the customers to re-order and maintain stock levels, service agreements and active product pricing.
Be first responder for all questions and customer communications to resolve supply, technical or general questions.
Field/Sales Team
Support the field team by providing them data, samples or marketing materials to help drive sales and customer adoption.
Assist in CRM platforms, contracts and order fulfillment.
Manage service and loaner parts/fleet as applicable.
Materials
Provide order fulfillment support, and general materials processes as applicable.
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
Operations
Education, Business Experience And Physical Requirements
| Reports to: | Manufacturing Manager |
| EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS | |
| · 2+ Years
· Electrical experience required · Solder experience · Startup, small business experience preferred |
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Required Competencies
This is a startup med tech company that requires a technician who is detail-oriented and proficient at building devices, fixtures and assisting in general areas. They need to be a self-starter who can work independently and thrive in a fast-paced environment.
Description Of Responsibilities
The Production Technician will build the Elucent surgical navigation system, which consists of an electromechanical chassis, computer, display, and an electrical patient pad. This will require understanding assembly drawings, electrical schematics and manufacturing procedures. This will require using equipment such as soldering equipment, electrical test equipment (oscilloscope, multi-meter), vision systems and standard mechanical tools for assembly.
Key Result Areas
Production
Build the production EnVisio systems and recommend improvements for manufacturability.
Assist in building fixtures and ancillary items to aid in production activities.
Perform mapping and additional activities to ensure functionality of EnVisio systems.
Perform depot and repair processes for the EnVisio system.
Research & Design
Build test articles and fixtures for prototyping and pilot needs.
Materials
Assist in kitting, cycle counting and general materials processes as applicable.
Education, Business Experience And Physical Requirements
- High School Diploma required
- 2+ Years assembly experience required
- 1+ years medical device assembly preferred
- Startup, small business experience preferred
Required Competencies
This is a startup med tech company that requires an assembler who is detail-oriented, willing to learn, and a self-starter.
Full-time , 1st shift, Monday Thru Friday.
Description Of Responsibilities
The Production Technician will assist in building the Elucent surgical navigation system, which consists of an electromechanical chassis, computer, display, and an electrical patient pad. This will require understanding assembly drawings and manufacturing procedures. This role may require using equipment such as electrical test equipment (oscilloscope, multi-meter), vision systems and standard mechanical tools for assembly.
Key Result Areas
Production
Assist in building the production EnVisio systems through the following activities:
- Kitting work orders
- Assembling EnVisio system sub-assemblies
- Performing mapping, accuracy, and isolation recordings
- Transferring released materials to inventory
Education, Business Experience And Physical Requirements
- 3+ Years
- Receiving & shipping experience required.
- Inventory management experience required.
- Work order generation, kitting and material logistics experience preferred.
- Medical Device/Manufacturing experience preferred.
- Startup, small business experience preferred.
- Physically lift and/or move 40-50 pounds
Required Competencies
Well-organized, motivated person who can manage an entire warehouse with speed and attention to detail. They will use our computer systems to ship, receive, kit work orders and manage inventory. They will be hands-on, moving materials, packaging, and labeling materials for shipment. They will work with supply chain, manufacturing, and customer service teams to execute on the business needs. Punctuality and good attendance required, as this role is critical to operations.
Description Of Responsibilities
The Inventory Operations Specialist will be primarily responsible for our warehouse and all corresponding processes. They will manage our incoming materials, as well as our customer shipments using our ERP system and standard shipping tools like FedEx Manager/UPS WorldShip.
They will use our ERP system to manage inventory locations and accuracies. They will generate and kit work orders for manufacturing.
They will package items for shipment, work with package carriers and occasionally help loading/unloading trucks with material handling equipment.
This is a first shift, 40-hour, non-exempt hourly position.
Key Result Areas
Shipping
Ship customer orders same day, with accurate materials, address information and rate of service.
Receiving
Receive supplier deliveries in a timely manner, maintain receiving documents, and inventory within the warehouse.
Work Orders
Generate and kit work orders for production, based on supply chain and plannings demand. Close work orders and ship/inventory the materials as necessary.
Inventory
Perform periodic accuracy counts and rearrange/move inventory for efficiency needs.
Education, Business Experience And Physical Requirements
- 5+ Years
- Medical Device, required
- Electrical experience, required
- Electrical troubleshooting experience, required
- Extensive solder experience
- Startup, small business experience, preferred
Required Competencies
This is a startup med tech company that requires a technician who can work independently to troubleshoot non-conforming capital systems and sub-components and identify root cause failure modes. They need to be a self-starter who can thrive in a fast-paced environment. A key element is creative troubleshooting with minimal guidance from engineering.
Description Of Responsibilities
The Senior Production Technician will investigate and conduct root cause failure mode analysis on the Elucent navigation system, which consists of an electromechanical chassis, computer, display, and an electrical patient pad. This will require understanding assembly drawings, electrical schematics manufacturing procedures, as well as the ability to trace the interaction of software programming with hardware functionality. This will also require using equipment such as soldering equipment, electrical test equipment (oscilloscope, multi-meter), vision systems, and standard mechanical tools for assembly.
Key Result Areas
Production
- Investigation and identification of root cause for non-conforming systems.
- Evaluation of returned capital assets for potential repairs and necessary upgrades as part of the depot service repair activities.
- Assist manufacturing engineering with process improvements, fixture development, and equipment maintenance and validations.
- Provide overflow capacity for standard production activities by assisting with capital asset builds, production release testing, and crating for shipment.
Research & Design
- Assist with experimentation and evaluation of new designs, processes, and software revisions.
Regulatory and Quality
Education, Business Experience And Physical Requirements
- BA/BS degree (preferably in Regulatory Sciences)
- Minimum 5 years of medical device Regulatory Affairs
- Proven track record with regulatory submissions.
- Experience preparing & defending regulatory submissions to the FDA (510(k)
- Knowledge of global regulatory requirements including EU, Canada and Asia.
- Demonstrated experience of basic engineering principles; electrical, mechanical and software
- Proven effective collaboration with regulatory agencies
- Ability to apply critical thinking on current global regulatory science questions.
- Individual must have a hands-on approach
- Strong organizational and time management skills
- Excellent technical/computer skills
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 project team in fulfillment of regulatory requirements for a given product and/or geography
- Works effectively on cross functional teams
Communication
- Excellent written and oral communication skills
- Ability to formulate responses to common inquiries from regulatory agencies
Description Of Responsibilities
The Senior Regulatory Affairs Associate will support the definition of the regulatory strategy for Elucent products. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will have an understanding of electromechanical devices. The ability to deal with ambiguity and think outside the box are critical for this position.
Key Result Areas
- Regulatory lead/representative on project core teams providing regulatory input on all matters
- Leads preparation, documentation and submission of FDA and other international applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes.
- Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
- Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA and other country-specific regulations as required.
- Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.
- Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.
- Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations.
- Reviews technical reports for incorporation into regulatory submissions
- Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced.
- Maintain current knowledge of relevant regulations and guidelines both proposed and final rules.
- Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
- Support post-approval products through change evaluation and submission.
- Other duties as assigned.
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
| Reports to: | R&D Engineering Manager |
| EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS | |
| · Required: BA, BS, or Master’s degree in electrical engineering or related field.
· Required: 3 years’ development experience in the medical device field · Proven experience developing complete products · Electrical systems development, troubleshooting, documentation, and testing experience in a regulated industry, medical device preferred · Hands-on experience in electrical systems deployment to medical device targets · Experience with electronics schematic capture and layout tools · Strong documentation and writing skills · Collaborates well with team members and functional area representatives · Strong verbal and written communication skills
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Required Competencies
- Strong knowledge of electrical development practices
- Electrical development, troubleshooting, documentation, and testing for medical devices
- Effective collaboration with other teams and functional departments to achieve project targets and objectives
- Generation and protection of intellectual property through innovation and proper use of procedures and documentation
- Ability to ensure compliance with company policies and procedures
- Strong knowledge of current applicable software regulations and standards
Description Of Responsibilities
The Electrical Engineer will develop electronics for an electromagnetic positioning system. The Engineer will deploy and maintain electronics as part of a project team that results in a complete, ready to sell electronics based surgical navigation product by a) designing new and maintaining existing schematics and board layouts, b) conducting testing and engineering studies to ensure performance, c) communicating status and results.
Key Result Areas
- Develop electronics for an electromagnetic positioning system
- The Engineer will deploy electronics as part of a project team that results in a complete, ready to sell electronics based surgical navigation product by a) designing new and maintaining existing schematics and board layouts, b) conducting testing and engineering studies to ensure performance, c) communicating status and results.
- Prototype assembly, evaluation and testing
- Formal verification testing
- Preparation of test protocols, reports and other documentation
- Component qualifications
- Build pilot and low rate production EnVisio systems.
- Recommend improvements.