Career Opportunities
At DFine, Inc. employees are our greatest asset. Our success depends upon recruiting and retaining talented, enthusiastic and dedicated people. We do this by providing them with a dynamic and challenging work environment in which to thrive.
We have a unique team that welcomes diversity of background and experience. DFine, Inc. is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
Open positions:
Product Manager
Contribute as a member of the marketing team in the execution of strategic and tactical marketing plans to fuel rapid growth. Core responsibilities are working with cross functional teams to drive the successful launch of all Dfine product offerings. This includes owning the product lifecycle, identifying new products, supporting product development efforts, managing the product launch and downstream product/market management efforts.
Authorities
Has authority to control product information/publications to assure no misbranding or misrepresentation to the marketplace occurs.
Duties and Responsibilities
- Identify new product ideas that address unmet clinical needs or represent material improvements to standard of care through insightful investigations with clinician customers, field sales representatives, and engineers
- Prioritize and select products for advancement through development process through business case assessment, using cross functional resources to understand regulatory, reimbursement, and professional education, legal and operational implications of product strategies.
- Develop product portfolio strategies that maximize sales force effectiveness and overall penetration of innovative technologies.
- Build synergistic relationships with key thought leaders in spine community.
- Interpret and manage clinical data efforts along with clinical champions for on market products.
- Monitor competitive activity to identify potential threats, while uncovering and exploiting opportunities arising from industry trends.
- Determine appropriate positioning and messaging of products to different customer groups and identify niche line extension opportunities through customer segmentation.
- Product Forecasting working cross functionally with Sales and Operations
- Forward all communications regarding 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 as a Product Complaint to QA per the quality system and the ISO/FDA regulations.
- Demonstrate a commitment to maintaining the quality system and products, visibly and actively, on a continuing basis.
- Responsible for obtaining post-market feedback on products.
- Responsible for knowing, understanding the quality policy, quality objectives and Standard Operating Procedures governing department.
- Other duties as assigned.
Position Requirements
- Demonstrated ability to get results through others.
- Experience interacting with medical community
- Ability to work collaboratively and independently in a dynamic environment is essential.
- Small group leadership and motivational abilities.
- Superior oral and written communication and presentation skills.
- Strong analytical and strategic thinking skills.
- Ability to deliver results with multiple and complex projects.
Education Requirements
- Bachelor's degree or equivalent. MBA or equivalent experience a plus.
Experience Requirements
- A minimum of five years experience in a marketing function with a proven track record of success
- A background in medical devices or healthcare products and in hospital-based sales models is highly preferred.
- Experience interacting with the medical community
Special Requirements
- Extensive experience and abilities with Microsoft Office
- Superior oral and written communication and presentation skills
- Approximately 30% travel required
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
Marketing Manager
Contribute as a member of the marketing team in the execution of strategic and tactical marketing plans to fuel rapid growth. Core responsibilities include Referral Marketing Programs, Patient Education Programs and Trade Show Management. Work with cross functional teams and the sales force to ensure marketing programs and events meet the needs of both internal and external customers.
Authorities
Has authority to control referral marketing and patient education information/ publications to assure no misbranding or misrepresentation to the marketplace occurs.
Duties and Responsibilities
- Drive the development and execution of comprehensive strategic marketing plan with a focus Referral Marketing and Patient Education Programs
- Develop and revise content (copy) on corporate website, unbranded websites, Referral Marketing/Patient Education presentations and collateral.
- Develop "turn-key" local marketing strategies that maximize sales force effectiveness and overall penetration of innovative technologies.
- Build synergistic relationships with key thought leader referring physicians who specialize in DFine's patient demographic.
- Assist in the development of clinical marketing presentations and programs geared towards sale call collateral and education.
- Manage Tradeshows and Events. This includes assessing which trade shows to attend with input from the marketing team, handle booth/congress logistics including onsite congress preparation and tear down and manage the logistics of trade show promotions.
- Develop with input from the Marketing Team, the promotional plan and elements for congress participation including congress theme, podium speakers, planned events/dinners, pre/post show mailers, give-aways, door drops and updating booth graphics as needed.
- Manage the logistics for spine specialist cadaver training courses nationally as needed. This includes hotel, facility, faculty, equipment scheduling as well as PO management with accounting and certificate generation.
- Attend conferences, clinical meetings and seminars as needed
- Manage collateral reorders for the company store
- Forward all communications regarding 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 as a Product Complaint to QA per the quality system and the ISO/FDA regulations.
- Demonstrate a commitment to maintaining the quality system and products, visibly and actively, on a continuing basis.
- Responsible for proper knowledge of the quality system as described in the Quality Manual.
- Responsible for knowing, understanding the quality policy and Standard Operating Procedures governing department.
- Other duties as assigned.
Position Requirements
- Demonstrated track record of success with results driven skill sets
- Experience interacting directly with medical community
- Ability to work collaboratively and independently in a dynamic environment is essential.
- Small group leadership and motivational abilities.
- Superior oral and written communication and presentation skills.
- Strong analytical and strategic thinking skills.
- Ability to deliver results with multiple and complex projects.
Education Requirements
Bachelor's degree or equivalent. MBA or equivalent experience a plus.
Experience Requirements
- Three to five years experience in a marketing function with a proven track record of success
- Background in medical devices or healthcare products and in hospital-based sales models is highly preferred.
- Experience interacting with the medical community
Special Requirements
- Extensive experience and abilities with Microsoft Office
- Superior oral and written communication and presentation skills
- Approximately 20% travel required
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
AR/AP Specialist
Responsible for full cycle AP for a select set of vendors. This individual is also responsible for processing invoices & credit memos for customers. Additional responsibilities include processing employee expense reports, reconciliation of bank statements, month end and year end reporting.
Authorities
Process vendor invoices and employee expense reports and generate customer invoices & credit memos in accordance with Company Policy. Resolve issues and discrepancies with both suppliers and customers.Duties and Responsibilities
- Audit approved paper expense reports against report backup, verify G/L coding of expenses and ensure stated T&E policies are followed
- Distribute invoices without purchase orders for management review, GL coding and approval
- Match purchase order related invoices to QAD receivers and resolve discrepancies when invoice, purchase order, and receiver do not match
- Enter payable documents in QAD for payment
- Match paid invoices to vendor checks for signature and file paid invoices
- Determine the appropriate Month end AP accruals. Set up new Suppliers in QAD and file completed W-9 forms
- Cancel A/P checks that have cleared the bank in QAD
- Reconcile the bank account at month end
- Assist with 1099 processing at year end
- Other GL Account reconciliations as required
- For Accounts Receivable, process both invoices and credit memos to customers, obtaining proper backup and approvals as needed
- Assist with month end close for both AR and AP
- Other GL Account reconciliations as required
- Other duties as assigned
Position Requirements
- Ability to process high-volume paperwork, data entry and filing
- Accuracy and attention to detail
- Ability to communicate effectively with employees, suppliers and customers
- Ability to meet deadlines and prioritize assignments with minimal supervision
Education Requirements
- Two year college degree or equivalent experience preferred
Experience Requirements
- 5-7 years related experience
Special Requirements
- Proficiency with Microsoft Word, Excel, Outlook and Accounting Software
Preferred Requirements
- QAD experience is preferred
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
Process Engineer
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 posses 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.
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
Regulatory Affairs Specialist / Manager
The individual is responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the individual is responsible for assessment of device changes for regulatory implications and develop strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner.
Authorities:
- Has the authority to identify deficiencies in regulatory submissions and design changes thereafter. Recommend strategies and documentation to comply with regulatory requirements.
Duties and Responsibilities:
- Develop strategies for regulatory approval of medical devices.
- Responsible for preparation and submission of 510(k)s, IDEs, and Technical Files (CE Mark) to support the multiple product lines.
- Identifies plans and develops strategies to meet the regulatory requirements that permit the successful registration of products worldwide.
- Identifies, develops, and implements worldwide regulatory strategy initiatives based upon business needs.
- Identifies, develops, and implements innovative process initiatives that promote efficiency of worldwide registrations.
- Organizes project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined.
- Will participate in new business development activities as needed. This position will require interaction with the U.S. FDA and other regulatory authorities around the world and will participate in audits and other applicable activities.
- Coordinate submission activities for a variety of device regulatory approvals including: US pre-market approvals, international design dossiers and/or technical files, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
- Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.
- Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization.
- Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
- Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
- Participate in training and mentoring of staff.
- Coordinate IFU development activities.
- Participate in department systems development initiatives.
- Prepare deliverables for Management Reviews.
- Develop innovative means to comply with regulatory requirements in an efficient manner.
Position Requirements:
- Proficient in use of MSWord, MSExcel, Powerpoint is required.
- Good writing skills and formatting skills.
- Ability to work well under pressure and handle multiple projects and meet deadlines.
- Ability to read and understand regulations, standards and procedures.
- Good leadership, analytical and interpersonal skills.
- Other duties as assigned.
Education Requirements:
- Bachelors Degree in scientific field is required or equivalent experience. A Masters degree is preferred.
Experience Requirements:
- 7+ years in Regulatory Affairs of medical devices.
- High level of attention to details and organization skills.
- Effective verbal and written communication skills.
- Demonstrated aptitude for preparing and submitting 510(k)'s in addition to preparation of EU Design Dossiers and experience with the GHTF.
- Prior interaction with the FDA and other worldwide agencies is required.
- Experience working with cross-functional teams is required in addition to previous aptitude thriving within a complex regulatory environment.
- Candidate must have the ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms.
- Thorough knowledge and understanding of FDA's QSRs, ISO 13485:2003 and MDD 93/42/EEC and other national/international standards.
- Hands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
- Manager must have the ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously. Previous experience mentoring and training staff is Preferred.
Preferred Requirements:
- Experience with spinal, orthopedic devices is a plus.
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
Senior R&D Engineer
Responsible for providing mechanical engineering support in the creation and the development of the product. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Authorities:
- Has the authority to identify and record problems relating to product and component design and to recommend or provide solutions to interface with vendors, order parts, fixturing for R&D purposes
Duties and Responsibilities:
- Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
- 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.
- Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
- Build and test prototypes designs for proof of concept.
- Develop and perform product verification and validation testing.
- Conducts feasibility studies to verify capability and functionality.
- Develops new concepts from initial design to market release.
- Directs support personnel and coordinates project activities.
- Maintains detailed documentation throughout all phases of research and development.
- Reviews or coordinates vendor activities to support development.
- 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.
- Provide support in the resolution of product complaints and/or safety issues.
- Enhance the intellectual property position of the company via invention disclosures and patent applications.
- Responsible for component documentation.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Position Requirements:
- Wide application of technical principles, practices, and procedures.
- Strong understanding of business unit function and cross group dependencies/relationships.
- Must posses good interpersonal and communication skills, and work in a collaborative style.
- Good technical skills and proven engineering problem solving ability.
- Hands-on design and development experience.
Education Requirements:
- Bachelor's Degree (Master's preferred) in Mechanical or Biomedical engineering.
Experience Requirements:
- Minimum of 10 years experience in engineering preferably in the medical device with successful track record of delivering products to market or developing commercially viable technology.
Special Requirements:
- Experience in CAD Tools (SolidWorks preferred).
- Advanced understanding of disciplined product development processes, regulatory and quality requirements, and the use of CAE design and simulation tools.
Preferred Requirements:
- Experience with designing parts for injection molding
Please send your resume to jobs@dfineinc.com, or fax it to Human Resources at 408.404.0863. Please include the job title in the subject line.
DFine Inc. is an Equal Employment Opportunity Employer.
Principals only, please.
We are hiring Territory Sales Managers and Regional Sales Managers
DFine is recruiting direct, highly motivated salespeople with a entrepreneurial spirit in all major cities. You must possess a 3-5 year successful background in spine device sales to be considered for a sales position.
If you are interested in pursuing a career at DFine please email jobs@dfineinc.com