Jobs at Werfen

Manages Operations supply chain projects involving supplier transfers, outsourcing, new parts, cost reduction, tooling, and fixtures. Defines project scope, timelines, resources, and deliverables; conducts cost-benefit analyses and presents business cases. Coordinates with suppliers, engineering, purchasing, quality, manufacturing, and management. Tracks risks and progress, improves processes, resolves conflicts, and supports projects from concept through implementation.

The IT Solutions Architect designs and implements customer IT solutions from pre-sale through go-live. Responsibilities include analyzing clinical and IT environments, developing workflows and network architecture diagrams, collaborating with sales and implementation teams, supporting project management, providing on-site and escalated support, addressing security and compliance requirements, and resolving technical gaps. The role requires customer-facing healthcare or medical-device experience, cybersecurity knowledge, and familiarity with interface technologies, connectivity, databases, and ADT/POCT devices.

Leads domestic and international logistics for regulated life sciences products, ensuring import/export compliance with U.S. and global regulations. Manages product classification, customs documentation, cold-chain shipments, transportation providers, customs brokers, freight forwarders, KPIs, audits, SOPs, regulatory changes, budgets, and corrective actions. Partners with Regulatory Affairs, Quality, Legal, R&D, Finance, and manufacturing teams to mitigate risk and maintain timely product movement.

Supports product management and marketing for Transplant diagnostic products. Coordinates market requirements, promotional programs, technical materials, product launches, field testing, sales training, and customer presentations. Collaborates with R&D, Operations, QA/RA, Technical Support, Supply Chain, and commercial teams while monitoring product performance and market developments. Requires healthcare or IVD experience, life sciences knowledge, strong communication skills, and 35% domestic and international travel.

Designs, develops, and optimizes embedded firmware for microcontroller-based motion control systems. Responsibilities include bare-metal and RTOS development, motor and sensor interfaces, low-level drivers, hardware bring-up, board-level debugging, peripheral integration, performance optimization, documentation, design reviews, and mentoring junior engineers.

Leads multiple large, multifunctional medical instrumentation product development programs from planning through manufacturing introduction. Oversees program managers and project managers, budgets of $8–13 million, scheduling, resource allocation, risk mitigation, design controls, vendor management, Agile execution, and executive communication. Collaborates across R&D, engineering, quality, regulatory, manufacturing, marketing, and sales while developing strategy, resolving conflicts, and coaching direct reports.

Manufactures and tests autoimmune diagnostic product components in the Bulk Formulations team. Follows SOPs, operates and cleans equipment, packages and fills components, evaluates raw materials, maintains manufacturing records, and complies with GMP, ISO, FDA, safety, and environmental requirements. Supports troubleshooting, quality improvements, and team operations in a regulated laboratory manufacturing environment.

Leads strategic, full-cycle recruiting for sales, marketing, and customer success roles. Partners with commercial leaders and People Business Partners on workforce planning, sourcing, job design, interviews, offers, employer branding, candidate experience, compliance, and recruiting process optimization. Builds talent pipelines, provides market intelligence, and uses recruiting analytics and technology to improve hiring outcomes.

Performs bench testing of finished diagnostic products according to SOPs, supports product and process validation, documents test results, maintains QC databases and laboratory supplies, and assists with investigations, complaints, nonconforming materials, and out-of-specification reports. Ensures compliance with quality systems, applicable regulations, and ISO standards while maintaining laboratory housekeeping and records.

Leads system integration, verification, validation, defect analysis, and remediation for medical device products. Translates user needs and system requirements into traceable test cases, executes system-level testing, analyzes risks and results, supports DFMEA and risk-control verification, and ensures compliance with medical device standards and regulations. Collaborates with cross-functional teams on issue resolution, product safety, design reviews, and readiness milestones. Some domestic and international travel may be required.

Supports and improves Quality Management System activities in a regulated medical device and IVD environment. Responsibilities include CAPA tracking, internal and supplier audits, quality agreements and plans, external document control, management reviews, metrics, audit support, change orders, and procedure improvements. Ensures compliance with GMP, FDA requirements, ISO standards, and related regulations while collaborating with cross-functional and affiliate quality teams.

Performs process development, characterization, optimization, validation, and qualification activities supporting new product introduction and platform initiatives. Plans and executes IQ, OQ, and PQ protocols; analyzes process data, trends, and capability; supports continuous improvement; develops moderately complex components and circuits; prepares specifications; documents engineering work; and provides technical guidance to engineers and technicians while ensuring quality and regulatory compliance.

Performs product bulking, filling, labeling, packaging, equipment operation, cleaning, inspections, and manufacturing documentation for diagnostic products. Follows SOPs, GMPs, safety procedures, ISO and FDA quality requirements. Identifies equipment issues, supports bulk manufacturing and packaging activities, maintains a clean work area, and contributes to production quality and goals in an on-site team environment.

Develops and validates automated manufacturing test systems for electro-mechanical medical diagnostic assemblies. Responsibilities include test fixture design, hardware selection, software and test sequence development using TestStand, LabVIEW, or equivalent, database integration, process validation, statistical analysis, root cause analysis, documentation, design control support, vendor collaboration, and technical mentorship.

Leads verification automation for regulated in vitro diagnostic medical devices across software, electrical, mechanical, and analytical disciplines. Designs and deploys test automation frameworks, develops and executes verification plans, protocols, and reports, and manages requirements traceability using Jama Connect. Provides technical mentorship, leads testing and integration activities, supports risk and design reviews, performs root-cause analysis, and drives project planning and process improvement. Requires extensive industry and regulated medical device testing experience.

Supports the development and enhancement of in-vitro diagnostic instruments through systems integration, design control, verification and validation, troubleshooting, risk assessment, and performance optimization. Collaborates with software, hardware, assay development, quality, manufacturing, and regulatory teams. Performs statistical analysis, reliability assessments, root-cause investigations, corrective actions, technical reviews, and documentation for design history files and regulatory submissions in a regulated environment.

Supports daily production operations across vialing, labeling, packaging, and solid-phase departments. Stages, moves, stores, inventories, and orders controlled components; verifies counts, labels, fill levels, and product quality; maintains accurate records and organized coolers; follows SOPs, FDA, ISO, OSHA, chemical, and biosafety requirements; investigates inventory issues and supports audits. The role requires physical handling of heavy carts, ladder use, prolonged standing, and close cooperation with manufacturing and quality teams.

Coordinates and processes engineering and quality change orders, maintains document and software libraries, manages SAP BOMs and routings, and supports document control across plants. Partners with engineering, manufacturing, quality, field service, and marketing to ensure changes are documented and implemented. Oversees quality manual documentation, periodic reviews, validation expirations, compliance records, and follow-up actions. May create technical drawings and models using engineering design software and provides subject matter expertise on change control procedures.

Leads production transfers and manufacturing process engineering for diagnostic products. Responsibilities include resolving process issues, root-cause analysis, continuous improvement, manufacturing quality planning, process documentation, equipment and tooling design, validation, new product introduction, supplier and R&D collaboration, and cross-functional project delivery. The role may supervise junior engineers and requires international collaboration and limited travel.

Supports employee relations, talent acquisition, recruiting, onboarding, HRIS administration, training, benefits and leave administration, compliance, HR programs, and workforce metrics. Partners with managers and employees, leads college recruiting initiatives, manages temporary hiring, supports immigration and relocation, and helps maintain employment policies and procedures. The role requires strong HR knowledge, communication, conflict resolution, organization, confidentiality, and familiarity with HRIS, ATS, Excel, and Microsoft Office.