Jobs at Evergen (evergenbio.com)

Supervises daily Quality Control operations in a regulated regenerative medicine manufacturing environment. Oversees inspections, reviews, product release, staffing, training, performance metrics, investigations, root-cause analysis, CAPA implementation, audit readiness, and continuous process improvement. Collaborates with Manufacturing, Quality Assurance, Engineering, Logistics, and other stakeholders to improve quality-system throughput and operational performance.

Leads quality engineering for medical device design and manufacturing projects, including risk management, CAPA, complaint handling, investigations, process validation, reliability engineering, and quality system optimization. Represents the company during FDA, notified body, and supplier audits, drives remediation, mentors quality engineers, and partners with senior leadership on quality strategy. The role requires advanced regulatory, statistical, and quality management expertise and includes up to 25% international travel.

Leads end-to-end CDMO project management for regenerative medicine and medical device programs, including plans, schedules, budgets, resources, risks, KPIs, stakeholder communication, client proposals, design transfer, pre-validation manufacturing, and regulatory compliance. Partners with commercial and global cross-functional teams, supports process scale-up and manufacturing improvements, prepares technical documentation, and maintains client relationships. This is a six-month, 100% onsite contract with potential conversion.

Supervises third-shift manufacturing staff, including scheduling, training, performance management, and corrective actions. Ensures safe operations, SOP adherence, quality checks, cleaning, environmental sampling, and production commitments. Investigates nonconformances through the quality system, tracks team metrics, supports product launches, and collaborates with processors, engineers, planning, and other shifts to improve output and cycle time.

Leads quality assurance engineering and cross-functional process improvement initiatives in a regulated regenerative medicine manufacturing environment. Supervises the QA Engineering team, reviews quality KPIs, validations, risk management, and nonconformance investigations, and supports regulatory submissions, product launches, change management, and continuous improvement. The role also oversees corrective actions, team development, technical documentation, and problem-solving activities.

Leads commercial operations for the Cortiva medical device business unit as a hands-on player-coach. Owns forecasting, Power BI reporting, sales analytics, pricing, GPO/IDN agreements, contract lifecycle management, ERP and data governance initiatives, CRM funnel management, and consignment inventory operations. Partners cross-functionally on CLM implementation, enterprise systems, automation, field inventory technology, and commercial process improvements while supporting pricing, contracting, reporting, and field inquiries.

Leads technical execution for regenerative medicine and medical device product development projects. Responsibilities include design control documentation, risk management, prototyping, experimentation, data analysis, regulatory compliance, vendor coordination, clinical needs assessment, intellectual property evaluation, and process scale-up support. The role collaborates with global cross-functional teams, authors engineering reports, maintains laboratory safety and documentation, and may mentor junior engineers. Travel is approximately 10%, and the position is fully onsite.

Supports quality assurance across product development, nonconformance investigations, CAPA, risk assessments, supplier qualification, validation, change control, audits, and process improvement. Reviews design and validation documentation, applies statistical techniques, maintains quality systems, and collaborates cross-functionally to ensure product quality, compliance, and patient safety.

Drives B2B growth for xenograft biomaterials and CDMO services across medical device markets. Responsibilities include prospecting strategic accounts, developing account strategies, translating processing capabilities into customer solutions, coordinating with R&D, regulatory, and manufacturing teams, negotiating deals, monitoring markets, attending industry events, reporting pipeline activity, and maintaining CRM documentation.

Serves as the site subject matter expert for microbiology, sterility assurance, aseptic processing, and contamination control. Oversees environmental monitoring, microbiological testing, validations, investigations, GMP documentation, CAPA, risk management, and continuous improvement. Trains staff, supports cleanroom operations, reviews quality records, and helps ensure regulatory compliance, product quality, and patient safety.

Manages multiple cross-functional R&D project teams, driving planning, execution, risk mitigation, stakeholder alignment, financial oversight, design control activities, and milestone delivery. The role ensures projects are completed on time, within scope and budget, facilitates decision-making and conflict resolution, communicates progress to executive leadership, and supports product development in a regenerative medicine CDMO environment.

Supports manufacturing engineering through equipment and process validation, control-system implementation, technical documentation, inspection planning, quality remediation, CAPA and non-conformance investigations, capital equipment projects, and new product launches. Leads continuous improvement using time studies, value stream analysis, flow analysis, and lean manufacturing methods. Collaborates cross-functionally to improve quality, cost, delivery, capacity, and safety within the company’s quality system.

Lead upstream and downstream marketing strategy for the Cortiva medical mesh portfolio. Own portfolio strategy, customer insights, market segmentation, pricing, commercialization planning, innovation priorities, clinical evidence strategy, and KOL engagement. Partner with R&D, Clinical Affairs, Regulatory Affairs, Compliance, Sales, and Operations to support responsible growth within reconstructive surgery and regenerative medicine while complying with regulatory and promotional requirements.

Manages manufacturing operations, production goals, scheduling, capacity, inventory, materials, equipment, and performance metrics. Leads supervisors and employees through hiring, training, development, engagement, and performance management. Partners with planning, engineering, and quality teams to ensure safety, compliance, product quality, continuous improvement, waste reduction, and on-time delivery. Oversees investigations, audits, non-conformances, complaints, and safety initiatives in a regulated manufacturing environment.

Leads manufacturing engineering projects involving equipment and process validation, control system implementation, process improvement, capital equipment integration, non-conformance and CAPA resolution, and new product launches. Drives lean manufacturing, cost savings, capacity expansion, documentation, and continuous improvement initiatives while coordinating cross-functional teams and potentially overseeing engineers or technicians.

Leads cross-functional design transfer and process development projects for regulated regenerative medicine products. Evaluates scientific results, establishes testing criteria, applies Six Sigma and SPC, translates product designs into process specifications, develops test methods, and supports process automation. Coordinates validation, risk management, regulatory submissions, product launches, and quality improvements while identifying and mitigating technical and clinical risks. May lead teams and review technical documentation.

Supports supply chain, inventory, production, capacity, and cost planning through data analysis, reporting, forecasting, and continuous improvement. Develops queries, BI reports, operational metrics, and production analyses; supports SIOP planning, tissue yield optimization, quality audits, statistical modeling, and ROI analyses. The role is onsite, part-time up to 20 hours weekly, and requires collaboration across departments.