Career Opportunities at DFINE

At DFINE, employees are our greatest assets. Our success depends upon recruiting and retaining talented, enthusiastic and dedicated people. We do this by providing a dynamic and challenging work environment in which our employees can thrive.

We are a unique team that welcomes diversity of background and experience. DFINE is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

Sales – 1

Scientific and Medical Affairs – 1

Process Engineer – 1

Sales Analyst – 1

 

Territory Sales Manager

Position Summary
Sales and territory management responsibility within a designated geography.

Authorities

  • Has authority to make decisions and implement programs/action items within the specific province of sales in a designated geographic area.

Duties and Responsibilities

  • Execution of sales plan
  • Management of accounts within sales territory
  • Presenting DFINE technology to physicians and facilities
  • In-service of DFINE products to physicians and facilities
  • Must be capable of providing verbal technical assistance as it pertains to the use of our products/systems in compliance with approved Information for Use documentation
  • Maintain up to date Vendor Credential requirements for all accounts within your respective geography
  • Complete and submit Case Reporting Forms for all cases conducted within your respective geography
  • Effective management of DFINE consignment inventory including but not limited to monthly count, expiry management, product exchange/return
  • Effective management of territory expenses against budget
  • Conduct your business and interactions with customers/accounts in strict compliance of AdvaMed guidelines
  • Report all Product Complaints (any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution) and all relevant information on the complaint to DFINE headquarters in San Jose in a timely manner
  • For Product Complaints, ensure all related and/or affected devices are returned for investigation to DFINE headquarters in San Jose
  • For all incidents related to Patient Injury, provide all relevant information to DFINE headquarters to meet the USFDA's Medical Device Reporting guidelines
  • Be aware of the Company's Quality Manual and Quality Policy
  • Other duties as assigned

Position Requirements

  • Excellent written and oral communication skills
  • Extensive knowledge of OR medical device market
  • Excellent negotiation and closing skills
  • Demonstrated ability to plan and execute
  • Documented history of achievement
  • Proficient computer skills specifically related to Microsoft Office
  • Must demonstrate a confident, hard charging, winner's presence
Education Requirements
  • 4-year Bachelors degree or equivalent experience

Experience Requirements

  • 5-7 years O.R. sales experience with focus on but not limited to: spine, orthopedics, neurosurgery, interventional radiology
  • Background must include successful record of achievement in both capital equipment and disposable sales
  • Top 10% record of achievement in prior positions
  • Superior knowledge of territory and current customer relationships

Click here to apply for this position.
 

Manager, Clinical Affairs – Ablation Technology

Position Summary
Responsibilities encompass the overall management of medical device projects including budgeting, timeline adherence, internal and external communications and project deliverables. This position will interact with operations, marketing and finance to ensure the successful relay of clinical trial data to further enhance the value of DFine medical devices. Special emphasis will be on ablation related technology and activities.

Authorities

  • Has authority to make decisions and implement programs/action items within the specific province of clinical sciences.

Duties and Responsibilities
Project Management:

  • Provide project/study management for U.S. and European Clinical Trials consistent with applicable regulations, guidelines and policies
  • Act as liaison with clinical sites
  • Assist with determining study objectives, strategy, and scheduling in order to meet business objectives
  • Manage protocol and investigator brochure development
  • Assist with the planning, preparation and presentations at Investigator and Industry Meetings
  • Other duties as assigned

Study Related Material Development and Review

  • Manage case report form development and approval.
  • Prepare, review and approve monitoring plans.
  • Prepare and approve final study documents such as study manuals, worksheets etc.

CRO/Investigator/Site Management

  • Lead activities performed by Contract Research Organizations
  • Assist with Investigator and site selection
  • Conduct audits of CROs and other outside vendors as necessary
  • Perform and oversee site qualification and activation activities
  • Assist with Investigator and site staff training
  • Lead and perform clinical monitoring activities as needed to ensure compliance with the investigational protocol, good clinical practices and appropriate regulations

Quality/Regulatory

  • Complete annual reports and safety reports and Regulatory clinical reports

Training/Scientific Meetings/Other Duties As Assigned

  • Attend relevant scientific/medical meetings as needed
  • Lead the development, review and approval of departmental SOPs
  • Manage training of CRAs, Consultants, and Contract CRAs
  • Coordinate regulatory activities including approval of clinical trials and product certification
  • Full knowledge of competitive systems
  • Maintain current on clinically related literature
  • Responsible for other duties and projects as assigned

Position Requirements

  • Management experience including outsourcing to CROs, excellent organizational and planning skills and management of investigational sites is essential
  • Strong working knowledge of Good Clinical Practice is required
  • Excellent written and oral communication skills
  • Proficient computer skills specifically related to Microsoft Office
  • Basic clinical research statistical method experience
  • Be aware of the Company’s Quality Manual and Quality Policy

Education Requirements

  • B.S. in Biological Sciences or related field and 5-10+years clinical research and development experience in medical device industry (some of which may be biotech/pharmaceutical industry) setting.

Click here to apply for this position.
 

Process Engineer

Position Summary:

Design, develop, and evaluate manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Duties and Responsibilities:

  • Design and develop manufacturing processes for new products and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost
  • Use statistical software to evaluate current manufacturing processes and recommend changes necessary to ensure acceptable machine or process capability (Cpk) levels
  • Must be very proficient at creating Control and Pareto charts, graphs, and other flowcharts necessary to characterize manufacturing processes
  • Responsible for ensuring proper documentation consistent with company’s quality system.
  • Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives
  • Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
  • Responsible for identifying issues in manufacturing and resolving them per the quality system requirements
  • Proactively work with QA/RA to ensure any and all issues are addressed per the requirements of the quality system and ISO 13485, MDD and QSRs
  • Ensure changes to processes have thorough justification and where applicable, validated to meet the regulations and the Company’s quality system
  • Ensure new tools/jigs, fixture, equipment or modifications to existing such items are only introduced in manufacturing upon completion of IQ, OQ, PQ applicable to the tools/jigs, fixture, equipment
  • Ensure the manufacturing processes meet the approved MPIs, STMs, QPIs, etc.
  • Ensure all equipment, tool, fixtures used for testing are calibrated, as appropriate, and/or inspected/verified to be traceable within the Quality System (per SOP 0005) and conforming to their specifications
  • Ensure the test protocols and reports are thorough, complete, provide all required details to reproduce the study at a later date. Ensure the data sheets for the studies are well designed to capture all required data
  • Perform process-related design tasks to support pilot manufacturing
  • Support production of final product by troubleshooting manufacturing processes.
  • Identify suppliers and maintain relationships to ensure the delivery of superior components and services
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
  • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions
  • Support company goals and quality policy, quality objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations

Position Requirements:

  • Must possess good interpersonal and communication skills, and work in a collaborative style
  • Good technical skills and proven engineering problem solving ability
  • Must have the ability to mentor junior Engineers and Technicians

Education Requirements:

  • Bachelor’s Degree (Master’s preferred) in Electrical, Manufacturing, Mechanical or Biomedical engineering

Experience Requirements:

  • Minimum of 5 years experience in engineering preferably in the medical device and/or pharmaceutical industry

Special Requirements:

  • Experience with Injection Molding Processes a Plus
  • Experience with statistical software preferred
  • Experience using CAD tools (SolidWorks preferred)
  • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability

Click here to apply for this position.
 

Sales Analyst

Position Summary:

  • This position has responsibility for working with the Marketing, Sales, I.T., Finance and Management Teams to develop and implement market intelligence strategies and clearly communicate insights based on well analyzed, high-quality information. The position also is responsible for the development and system administration of a CRM system. The position will also administrate the Quotas, Compensation Plans and other activities related to the direct support of the Field Sales Organization and Sales Management Team. The position has responsibility to Primary audiences of Senior Management, Sales, Finance, CFO, Marketing and Field Sales Management.

Authorities:

Has authority to complete action items based on direction from Vice President of Sales and Sales within the specific province of sales administration, analysis, sales controller and systems administration

Duties and Responsibilities:

  • Analyze both internal (sales) and external (secondary audit) data to support all levels of the organization in considering our business and in improved decision-making.
  • Provides analytical and strategic support to executive and senior management in performance tracking, promotional targeting, sales force deployment and expansion, compensation planning, quota setting, and sales force effectiveness.
  • Synthesize information from various sources to optimize or improve sales force alignment/deployment.
  • Effectively communicate strategic and tactical implications of analysis and assessments to appropriate audiences throughout organization.
  • In conjunction with Product Manager, generate sales and production forecasts for existing and new products, as well as develop decision models/forecasts to support business development initiatives.
  • Collaborate with other employees in the organization (Marketing, R&D, and Clinical) to perform market evaluations and assessments. This would include performing market sizing exercises and running scenario analyses to assist in decision-making.
  • Collaborate with product teams in interpreting historic trends and market dynamics in order to forecast future trends for each product line, as well as future market potential/available market potential.
  • Develops and executes marketing research programs and analysis providing both strategic and tactical recommendations in key areas of commercial activity. This would include both market research efforts (product/brand positioning, customer satisfaction, market/competitive intelligence, advertising testing and tracking) and sales analytics (targeting, alignment, and capacity planning)
  • Perform ad hoc analytical projects as identified by the VP and/or Directors of Marketing and Sales, and other key internal stakeholders.
  • Serve as functional owner of and/or expert on any/all data repositories within DFINE.
  • Follow the Company’s Quality Manual and be aware of the Quality Policy.
  • Develops a CRM System and Administrates that System
  • Provides Sales Administration of the Quotas and Compensation Plan.
  • Other duties as assigned.

Education Requirements:

  • 4 year degree or equivalent experience
  • MBA or advanced degree greatly preferred

Experience Requirements:

  • At least 5 years of relevant experience
  • Expert in MS Excel, including facility with "advanced" features such as pivot tables, vlookup, use of macros and add-ons.
  • Experience with CRM Systems & Tools
  • Experienced in short and long-term forecasting. This might include epidemiology-based forecasting, time series forecasting, production forecasting, or similar.

Click here to apply for this position.