Status:
Full Time, Exempt
Reports To:
Director, Tissue and Biologics R&D
A. Purpose and Scope of Position
The R&D Engineer I will initiate the development of new tissue products during the complete design project execution through ideation, development, validation, and design transfer to production. This position will initiate the monitoring of current production processes with the goal of the implementation of process improvements to improve efficiency, throughput, and cost in the production of tissue products. This position will drive experimentation development, validation development, and protocol/report generation, and assist in design control activities.
This position will provide support to the initiatives of R&D team as needed with execution of complex projects with support.
B. Organizational Relationship
This position reports to the Director, Tissue and Biologics R&D.
C. Duties and Responsibilities
Specific Job Duties/ResponsibilitiesDevelop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company Support Xtant Medical’s mission, values, and Quality PolicyMaintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPsDevelop and maintain an understanding of the Xtant Medical 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 applicableAdhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocolsComplete annual SOP review and OSHA safety training as applicableExecute assigned tasks associated with product development including ideation, process development, validation execution, protocol and report writing, SOP writing, and design transfer with assistanceDemonstrates complex engineering knowledge and demonstrates basic knowledge and expertise in technologies aligned with company and departmental goals. Works independently to complete engineering assignments and resolve technical challenges with infrequent direction from supervisor. Applies appropriate engineering design to simple component developmentAbility to solve problems and design experiments with infrequent assistance. Expected to make suggestions or improvements based on recent technical knowledge and help implement the improvementsApply knowledge and skills to provide input during the review of existing processes or equipment for improvements in efficiency, process productivity, and cost. Assist in the evaluation of process improvement projects for feasibility and compliance with current validations, common practices, and regulations. Assist in the evaluation of the extent of revalidation needed for process changesDesign experiments and interpret experimental data generating informed analytical decisions for process improvement. With minimal assistanceDevelop and manage single projects across process development and product development using project management skills with a focus on achieving cost and timeline objectives for capital expense projectsExecutes basic problem solving for technical issues and/or complaints for existing productsParticipate in existing product/process development by evaluating data from production, NC/complaints (with root cause investigation), and engineering studies. Develop processes, with assistance, which meet safety and regulatory requirements and provide for the safety and well-being of operators, maintenance, and other personnelComplete associated validation work, when necessary, with infrequent assistance, adhering to current regulations and requirementsContribute towards the implementation of new equipment with minimal assistance when necessary for process improvement and product developmentParticipate as a team member on equipment, product and/or process development projects.Develop and maintain a fundamental understanding of Xtant Medical products, operational processes, and general biological and chemical systems utilized within the Company. Understand how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production and quality of medical devices and tissuesAssist in Design Control activities such as Risk Management, trace matrixes, Verification and Validation, providing input for design specifications, developing workflows, writing work instructions and SOPs, gate reviews etc.Assist in identifying and mitigating safety and efficacy risksWrite and/or revise SOP’s, Work Instructions, Forms, Protocols, Reports, and other documentation with support. Train staff on changes to documentsWork with Quality teams to ensure processes meet Quality and Regulatory requirements for CFR 1271, CFR 820, ISO 13485, and Good Manufacturing Practices (GMP)Develop an understanding of system requirements for Enterprise Resource Planning (ERP), and any other changes to existing processes and line extensions, making SOP changes as necessary, with supportFinancial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement PolicyTrainingParticipate in training plans and programs and complete in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskAssist in the training of Processing staff as neededManagementThis position does not supervise othersWorks with and supports the activities of the Director of Process Engineering. Autonomously executes key initiatives on small projects with minimal oversightHelps ensure the team delivers the highest standard of departmental and cross-departmental teamwork and customer serviceDocument Control and Record ControlWrite, review, and revise a variety of technical documents including SOPs (Standard Operating Procedures), specifications, training documents, and processing protocols as needed.Legibly and accurately complete all documentation associated with assigned duties and review the information of others as required.Initiates changes to documents and to products and processes.Train on and demonstrate proficiency in Xtant Medical’s document control systemOther duties as assignedPerformance of DutiesComplete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to datePerform all duties according to established procedures and follow appropriate safety precautions and measuresSupports operating units by identifying and clarifying problems; evaluating potential solutions; implementing selected solutionMust maintain confidentiality of donor and recipient information according to HIPAAProfessional and courteous interactions with fellow employees, surgeons, staff, and end users are expected at all timesD. Job Requirements
Education/Credentials Experience & TrainingBachelor’s degree or higher in an Engineering or Science field is required (Mechanical Engineering, Biomedical Engineering, etc.). Preferred knowledge areas: biology/cell-biology/biochemistry, anatomy, and physiologyTwo (2) – five (5) years’ R&D engineering experience is requiredTwo (2) – five (5) years’ GxP environment is preferredSix Sigma Green Belt or Black Belt is strongly preferredMust have or be willing to acquire Certified Tissue Bank Specialist (CTBS) certificationExposure to Medical Devices and/or Tissue Banking preferredExposure to design control methodology is requiredProven experience in providing support to small and medium sized product development initiativesApplied knowledge of process improvement and project management methodologies is strongly preferredExposure to a heavily regulated field is strongly preferredTechnical Requirements/SkillsExposure to current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR) is requiredUse of Problem Solving and Process Improvement Methodologies (e.g., 6 Sigma or DMAIC)Requires the ability to apply scientific and analytical principles for proper design of experiments and validations and provide sound interpretation of resultsKnowledge of FDA and ISO regulations and standards preferred; knowledge of AATB standards preferredExperience with Process Mapping is desiredApplied knowledge of project management methodologies preferredExperience in the management of small to medium high priority development and design projects is preferredExperience in reviewing and editing simple technical documentsExposure to the writing of simple validation protocols and reportsWorking Knowledge in SolidWorks or equivalent modeling software and Microsoft Office ProductMust possess excellent organizational skills and strong attention to detailA demonstrated ability to perform in cross-functional teams to achieve objectives within required time framesExperience in participating in departmental projects and small cross-functional projectsExposure effective literature search activities3. Managerial Experience
4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
- Must be able to work independently with minimal guidance
- Must be a team-player, able to constructively engage with cross-functional associates. Able to effectively work with external vendors, partners, agencies etc. as necessary
- Able to work in a standard office setting, use standard office equipment, and to attend on-site and off-site meetings
- Must be able to adapt to quickly changing priorities and schedules
- Must possess mobility to work in a standard office setting and use standard office equipment
- Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority of position
5. Working Conditions
- Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
- Work may require frequent weekend/evening work at times during the course of a project
- Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
- Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks, as necessary
6. Health and Safety
- Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
- This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
- Will require experience or training in the routine handling of chemicals and biohazards
- May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
- Must be able to lift 60 lbs.
- Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver
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.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.
55000.00 To 70000.00 (USD) Annually
