Xtant Medical

Principal Engineer – Hardware

Title: Principal Engineer – Hardware
Status: Full-Time, Exempt
Director of Hardware Engineering
Location: Remote U.S.

Summary:

Why Xtant Medical?

JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.

Position Summary

Xtant Medical is seeking a talented and dedicated Principal Engineer that will support the company mission to market regenerative medicine products and medical devices.  The Principal Engineer is a critical role in the Hardware Operations and Product Development functions.  This position is responsible for designing, executing, and interpreting experiments that contribute to the development and accomplishment of project strategies.  This position will direct project team members, and other support personnel, throughout all phases of new product development while identifying and mitigating business risks.

Principle Duties & Responsibilities

  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO); European Medical Device Directives (MDD); and Canadian Medical Device Regulations, as applicable, and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
  • Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
  • Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
  • Leads brainstorming sessions to yield ideas and concepts to solve problems, while generating leading ideas and Pugh selection matrix
  • Guides concept selection and inspires creativity in team. Mentors others on conceptualization and innovation process
  • Creates test plans and new test protocols within and outside one’s knowledge area
  • Assists with fixture designs
  • Oversees outside test services
  • Independently writes reports on testing protocols and designs
  • Maintains test equipment and teaches others on test methodologies
  • Advises and mentors other with regards to statistical analysis and determination of sample size requirements in order to meet quality and reliability objectives
  • Creates drawings with advanced views, details, table, etc. and performs 2D tolerance analysis and fits
  • Creates assembly drawings and applies basic GD&T
  • Creates drawing layouts/templates, performs 3D tolerance analysis and mastery of drawing standards
  • Proactively communicates with suppliers to create specifications and resolve manufacturing issues
  • Communicates directly with management on course of actions needed without assistance through internal and external communication that clearly defines key technical and management issues
  • Identifies and mitigates business risks and leads knowledge sharing of best practices, training, research, etc. with appropriate staff across all departments
  • Motivates team members and peers to facilitate team building and project progression, identify and resolve interpersonal problems, and reduce complex engineering issues to assist non-engineers in understanding risk, opportunities and relevant data
  • Actively cultivates an environment of trust for all team members. Seeks and delivers feedback with appropriate candor for the sake of team performance, while being committed and accountable to the construction and delivery of team goals.  Is actively supportive of team decisions even if not preferred decision
  • Maintains collaborate relationships across departments
  • Acts as lead investigator for complaints and other critical issues
  • Takes an active role in developing department resources and people to meet strategic goals
  • Acts as project leader and/or technical lead for development projects within or outside of one’s area of expertise from concept to completion
  • Evaluates surgeon ideas for technical and business feasibility while ensuring conformity with company goals
  • Collaborates with surgeons or teams to connect clinical experience with design specifications
  • Creates and directs the creation of design inputs from user needs and marketing requirements
  • Designs, executes and interprets experiments that contribute to the development and accomplishment of project strategies
  • Oversees the activities of junior engineers and temporary staff as necessary
  • Directs project team members and other support personnel for all phases of new product development
  • Creates detailed and accurate project plans and estimates for resources – determines tasks, budget, labor, materials and time required to complete projects. Mentors junior engineering staff on project management best practices
  • Leads in the preparation and presentation of materials for internal and external technical reviews
  • Reviews, edits and approves internal documentation for other team members
  • Sets up and leads cadaver evaluation of products and functions as an expert technical advisor for products in surgeries
  • Upholds design control procedures and leads in the creation of new processes and procedures as necessary
  • Prepares engineering documentation including engineering drawings, test plans, manufacturing instructions, design verifications and validation protocols, engineering charge notices, DHFs, and other supporting engineering documents. Will audit said documentation for compliance to internal and external requirements
  • Compiles and maintains a DHF that is organized, thorough and up to date throughout the life of a project
  • Creates intellectual property, draft claims, and prepares patent applications in conjunction with attorneys. Conducts comprehensive patent research and analysis for determination of FTO and to specify design alternatives and/or constraints as needed
  • Leads risk management teams during the creation of risk management files, identifies and mitigates safety and efficacy risks, identifies hazards, causes and the mitigation of risks. Shares best practices with other appropriate staff across all business units of identified risks

Approvals

  • Primary approver of Drawings and Nonconformance Reports
  • Engineering approver for design control documents (Design Matrix, FMEA, Protocols/Reports, etc.)
  • Engineering approver for DCNs

Education/Knowledge/Skills Required

  • AS/AT in Engineering or equivalent discipline with 15 years’ experience; BS in Engineering discipline with 10 years’ experience or Advanced Engineering degree with 8 years’ experience
  • Minimum of three (3) projects from concept-to-launch of large scope required

Technical Requirements/Skills

  • Master of multiple disciplines or technologies critical to company goals. Examples include project management, locking screw technology, screw design and performance, 3D modeling and computational analysis, additive manufacturing, etc.
  • Proficient in SolidWorks or equivalent modeling software, Microsoft Office products, Liquid Planner, Minitab and other software required
  • Possesses strong knowledge of anatomy, physiology, mechanics, kinematics, and other technical fields across specialization area
  • Subject matter expert in the selection of engineering materials, material properties and processing thereof
  • Knowledgeable on basic print reading and understands drawing layouts
  • Advanced GD&T knowledge
  • Must possess excellent verbal and written communication skills
  • Advanced skills in technical writing and review of protocols, reports, and technical memos
  • Ability to identify new product opportunities and is knowledgeable of competitors and market movements
  • Must possess knowledge on current or emerging technologies across a market segment
  • Must have a keen understanding of business and financial impact of projects
  • Advanced knowledge of multiple disciplines or technologies critical to company goals, such as project management, screw design and performance, 3D modeling and computational analysis, additive manufacturing, etc.
  • Advanced ability to resolve complex problems, including ability to develop new test methods at identifying root cause and demonstrating resolutions
  • Expert knowledge in DMAIC process
  • Advanced understanding of project management principals to effectively complete project milestones and achieve desired outcomes
  • Ability to manage project risks and solve complex project related conflicts and issues
  • Demonstrates in-depth knowledge of medical terminology and procedures related to medical devices across multiple applications
  • Ability to complete complex design and engineering tasks, within one’s core knowledge area, which requires the development of new or improved techniques and procedures Resolution of technical issues outside of one’s core educational field may require assistance
  • Must possess excellent organizational skills and strong attention to detail
  • Ability to investigate and analyze information and to draw conclusions
  • Must have strong interpersonal skills and be able to continually converse and interact with people from varied backgrounds

Managerial Experience

  • Ability to train, cross-train, direct, and mentor others

Special Requirements/Physical Capabilities or Abilities, other Additional Desirable      Qualifications

  • Must be able to reason independently and work with minimal guidance
  • Ability to interpret data and make sound judgments based on those interpretations
  • Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
  • Must be able to adapt to quickly changing priorities and schedules
  • Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
  • Must possess mobility to work in a standard office setting and use standard office equipment
  • Must be able to prepare and make presentations to staff, board members, clients, potential clients, investors, and others as required
  • This position will require traveling. Up to 25% travel may be expected

Note:   This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

This position does not offer H-1B Visa Sponsorship.

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.