OrganOx

Full-stack Engineer

• As the leader of a small multi-disciplinary Product Engineering team, and under the direction of the SVP, Product Engineering, the successful incumbent will drive activities in the following areas:
• - Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones.
• - Orient quickly to understand new quality issues based on field or factory performance, and to concurrently manage multiple projects with different teams and while balancing competing priorities.
• - May take direct responsibility for design-related CAPAs (Corrective and Preventive Action) within the Product Engineering department as well as process focused CAPAs.
• - Author investigation (i.e., root cause analysis) plans, reports, and supporting documents of high quality (i.e., submission and audit/inspection ready) that are technically sounds, critically reasoned, and use appropriate root cause tools/methodologies (e.g., 5-Whys/Cause Map, Contradiction Matrix, other DRM/Six Sigma problem-solving and statistical analyses).
• - Provide clear and concise communication – both written and verbal. Author strong documentation with attention-to-detail that is audit-ready. Present team’s investigation findings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders.
• - Plan schedule and resources (e.g., labor skills sets and duration, expenses) to achieve desired project outcomes.
• - Responsible for maintaining a focus on quality, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements, and ensure sound decision-making.
• - Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Director, Product Engineering

Recruitment

• **ABOUT ORGANOX:**
• OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx *metra*® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
• **Position Summary**
• We are seeking a dedicated Talent Acquisition Partner (TA) to join our HR team. Partnering with the HR team and hiring managers, the TA Specialist will be responsible for managing the full recruitment cycle, from identifying potential hires to screening and evaluating candidates.
• Listed below are the key responsibilities of the role and a brief description of some of the key activities to be performed. This list is not totally inclusive.
• **Key Responsibilities**
• **Recruitment:**
• Collaborate and partner with department heads and managers to:
• o Understand role requirements and determine sourcing approach for planned hire(s), optimizing for caliber, speed, & cost.
• o Develop and update job descriptions and job specifications.
• · Plan and conduct recruitment and selection processes (screening calls, interviews, etc.)
• · Assess applicants’ relevant knowledge, skills, soft skills, experience, aptitude and cultural fit
• · Provide direction to Hiring managers throughout entire recruitment process including offer details.
• · Consistent presence on social media (LinkedIn, various Med Tech industries/forums) to advertise open positions and
• generate networking opportunities
• · Seek out opportunities to increase our brand and provide recruitment opportunities – job fairs, alumni events, etc
• · Develop a preferred list of recruitment agencies. Source candidates both through agencies, and through direct channels such as social platforms and professional networks.
• · Model OrganOx mission and values in every interaction with Hiring Managers, HR Partners and all candidates.
• · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
• **Training:**
• · In partnership with HR Business Partner, coach Hiring managers in HR recruiting best practices to build capability across the company.
• · Train managers on ATS system
• · Provide instructions/details on our recruiting process from posting to offer stage
• **Data Analysis & Process Improvement**
• · Develop KPIs for various metrics
• · Develop consistent reports – weekly, monthly, yearly on status of recruitment process
• · Partner with FPA to review headcount, open roles, budgeting, etc.
• · Proactively design/implement opportunities to streamline recruitment processes
• **Contingent Workers**
• · Build good practice in managing contingent workers, including the management of status determination tests.

Talent Acquisition Partner

Engineer

• Design, analyze and implement operational workflows across US operations and supply chain.
• Identify opportunities for process improvements and participate in continuous improvement initiatives.
• Develop and maintain technical process documentation, including Standard Operating Procedures, Work Instructions and Process Maps.
• Gather and report process metrics.
• Develop and maintain procedures that ensure compliance to ISO13485 for Operations Projects that fall under the scope of the OrganOx Quality Management System (QMS).
• Create and review Specifications, Standard Operating Procedures and Work Instructions.
• Work closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations.
• Create and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support US Operations.
• Work collaboratively with colleagues at all levels in all departments to improve current processes and develop a culture of continuous improvement.
• Participate in the execution of US Operations Projects and work with cross functional teams to ensure successful execution.
• Support implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective of improving Safety, Quality, Delivery performance and Cost.
• Collect and analyze process data and recommend improvements.

Senior Process Engineer

Operations

• Manage the distribution and storage of OrganOx sub-components, spares, tooling and finished goods using approved distribution and warehousing partners.
• Identify and implement continuous improvement opportunities throughout the supply chain to improve Quality/Delivery/Customer Service/Cost.
• Manage daily operations and logistics in the US to meet business objectives.
• Support the Senior Manager, Operations in developing, implementing and monitoring KPIs to drive operational performance, cost efficiency and quality standards.
• Develop, implement, and maintain policies and processes to maintain inventory accuracy, adequate safety stock, and inventory records compliance.
• Provide regular structured communication to Senior Manager, Operations on operational performance in the US Region.
• Manage and monitor the performance of logistics partners using Business Continuity Planning, identify and mitigate risks and issues in the supply chain.
• Using formal mapping techniques, define the existing distribution network and identify updates to the network based on the business growth plan defined in the S&OP process.
• Cultivating a high-performance culture. Promote cross-functional collaboration and create opportunities for professional development within the team.

Operations Manager

Manager

• Responsible for architecture of the Quality Management System and all infrastructure elements to affect an efficient and effective QMS and oversee, configure, and continually improve document management, change, and control processes.
• Report directly to the Director, Quality Assurance.
• Build organizational capability by leading, developing, and inspiring a global QMS and Document Services team; create clear pathways for professional growth and succession.
• Collaborate across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization.
• Act as a visible quality leader engaging senior stakeholders to align QMS and Document Services strategy with company objectives.
• Provide strategic oversight of document management, change control, and MasterControl-based processes and identify ways to streamline and strengthen compliance.
• Define and manage resource requirements and ensure the team is equipped to deliver against business and compliance needs.
• Champion the use of quality metrics to inform decisions, continuous improvement, and reporting to leadership.
• Represent Document Services and QMS functions in Management Review, audits, and inspections.
• Ensure compliance with relevant international regulations and continuously evaluate compliance risks, implementing mitigation strategies.
• Lead organization-wide initiatives to build capability and engagement with quality systems and ensure effective budget management.

Manager – Quality Management System and Document Services

Account Manager

• Primary contact for all aspects of OrganOx commercial business in assigned territory
• Field-based, customer-facing role interacting at multiple levels and requiring total hospital account management skills and business acumen
• Ensure sales targets are met or exceeded and generate/follow-up on sales leads
• Understand market needs, establish strong customer relationships, and communicate product value
• Work closely with matrix team to develop strategies to promote products to medical professionals, hospital administrators, and other stakeholders
• Implement and execute launch strategies, provide product introductions and in-services for customers
• Complete territory analysis and identify key target accounts
• Monitor competition and share information with marketing team
• Build relationships daily with multiple customers within an account and manage supply/inventory communication
• Resolve customer complaints by investigating problems and recommending solutions to management
• Support market development efforts to increase patient availability for treatment
• Support execution of education programs for physicians and other health professionals to accelerate adoption
• Foster and maintain strong customer relationships via professionalism and presentations (virtual and in-person)
• Work cohesively with Clinical Specialists, marketing, medical, leadership, and matrix team to meet customer needs
• Participate in trade shows, conferences, and other industry events to represent the company
• Routine air and overnight travel (up to 80%); must reside within Dallas, Houston, or Austin area and be within 45 minutes of a major airport hub

Territory Manager

QA Engineer

• Lead root-cause investigations in response to customer complaints
• Support hands-on analyses of returned products to identify root causes of failures
• Support development of investigation criteria and test methods to properly diagnose and root cause field failures
• Analyze and trend on product performance data to provide recommendations for product improvements
• Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends and support timely closure of SCARs
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures
• Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
• Support CAPAs, Escalations, and engineering investigations in response to field quality issues
• Participate in the development and review of engineering change orders that impact product quality activities
• Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• Adhere to OrganOx’s Code of Conduct and company policies
• Collaborate with Product Sustaining Engineering and Contracted Suppliers to set quality control and management processes including sterilization, microbiology, supplier management, and contract manufacturing processes