Jobs at Werfen

Lead a portfolio of R&D programs and projects spanning hardware, software, and sustaining initiatives. Supervise program and project managers, oversee planning, scheduling, budgets, risks, design controls, resource allocation, and milestone reviews. Partner with executive leadership and cross-functional teams on strategy, product launches, vendor selection, and organizational improvements. Manage portfolios typically exceeding $10 million annually and support product development through manufacturing introduction.

Leads mechanical design and development of complex electromechanical medical diagnostic and IVD systems from concept through verification, validation, and design transfer. Develops manufacturable solutions involving motion systems, precision fluidics, thermal management, CAD modeling, simulation, GD&T, and tolerance analysis. Provides technical leadership, design-control documentation, defect and root-cause analysis, CAPA support, cross-functional collaboration, mentoring, and guidance on product architecture and engineering trade-offs.

Leads software testing for medical diagnostic systems, including feature, integration, system, regression, UI, API, performance, load, stress, and security testing. Develops automation frameworks, scripts, environments, and infrastructure; maintains traceability and reviews requirements and test code. Coordinates testing, leads a small team, mentors staff, ensures medical device regulatory compliance, and drives continuous process improvement in an Agile/Scrum environment.

The Contract Analyst supports North America Commercial Operations through contract drafting, redlining, negotiation, administration, compliance monitoring, reporting, document retention, audits, and contract system management. The role collaborates with Finance, Legal, Compliance, customers, and commercial teams, while supporting contracting communications and matter intake. Domestic and international travel may be required up to 10% of the time.

Manages the Detection Systems and Algorithms team within Hardware Engineering, overseeing optical engineering, electro-optical detection systems, machine vision, digital signal processing, and algorithm development. Responsibilities include technical leadership, staff development, resource and budget planning, project prioritization, quality and delivery oversight, cross-functional coordination, roadmap development, and technical problem resolution. The manager also serves as a player-coach and subject matter expert supporting medical diagnostic products throughout their lifecycle.

Provides domestic and international technical support for transplant diagnostic products through phone, email, and on-site assistance. Troubleshoots software, instrumentation, and assay issues; conducts research, testing, investigations, and root cause analysis. Delivers customer demonstrations and training, maintains quality records, supports product launches and UAT, and participates in industry events. Requires strong HLA, antibody detection, molecular assay, Luminex, and next-generation sequencing expertise, with up to 50% travel.

Plans and conducts advanced scientific assignments using experimental design and specialized expertise. Defines project objectives, selects technical approaches, develops solutions, documents results, writes technical reports, monitors scientific literature and competitive products, and may direct other scientists or represent the company externally. Requires a Ph.D. or equivalent scientific education, with professional experience preferred. Travel is less than 5% and international mobility is not required.

Leads global marketing strategy and lifecycle management for an on-market hemostasis reagent portfolio. Responsibilities include product positioning, pricing, market segmentation, launch execution, competitive analysis, customer engagement, revenue growth, forecasting, and portfolio performance. Partners with R&D, Clinical Affairs, Regulatory Affairs, Quality, Operations, Technical Services, and Sales to support product development, commercialization, sustainment, and end-of-life planning.

Develops and tests software for diagnostic systems, contributing to requirements, architecture, design, coding, integration, and defect resolution. Participates in code, design, requirements, and test reviews; manages requirements changes, risks, releases, and documentation. Performs unit and integration testing across software and electrical or mechanical devices, implements fixes and change proposals, estimates work, and follows engineering standards and project procedures.

Leads small to mid-size medical instrumentation product development projects or major program sub-projects. Responsibilities include project planning, scheduling, budgeting, risk management, design control, technical leadership, vendor coordination, issue resolution, stakeholder communication, and cross-functional collaboration with engineering, quality, regulatory, manufacturing, marketing, and other teams.

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, peripheral debugging, real-time optimization, technical documentation, and mentoring. The role requires close collaboration with hardware engineers and advanced debugging using JTAG, oscilloscopes, logic analyzers, and function generators, with emphasis on reliable, safety-critical medical-device systems.

Supports the development, implementation, maintenance, and tracking of role-based training programs and materials. Ensures training assignments meet regulatory, procedural, and compliance requirements; coordinates training requests and completion tracking in SAP; supports learning platforms; and advises stakeholders on adult learning interventions using the ADDIE model.

Plans and leads small-to-mid-size software and medical instrument product development projects and related programs. Responsibilities include scope definition, scheduling, resource planning, budgeting, milestone reviews, Agile Product Owner duties, risk and issue management, design control documentation, vendor oversight, and executive communication. The role coordinates cross-functional teams across R&D, quality, regulatory, operations, marketing, sales, and service to deliver product changes and new product introductions.

Provides technical and clinical hemostasis expertise to sales, applications, corporate accounts, and customers. Supports competitive displacement, account retention, test-menu expansion, instrument and reagent demonstrations, customer evaluations, educational presentations, employee training, and trade shows. Requires at least five years of related experience, including one year in a clinical laboratory, a science degree, and MT (ASCP) or equivalent licensure. The role involves approximately 75% travel.

Administers and secures local area networks, including servers, workstations, routers, modems, peripherals, user access rights, and email access. Installs, configures, monitors, troubleshoots, and maintains hardware and software. Supports employees, manages inventories, coordinates vendor repairs, prioritizes resources, and may supervise assigned network administrators. Requires a related bachelor's degree or five years of similar experience, with travel under 5%.

Leads software test automation for cloud-based clinical decision support solutions. Designs and maintains enterprise test frameworks, automated UI/API/integration/system/regression suites, and CI/CD integrations. Collaborates with engineering, product, DevOps, quality, regulatory, and clinical software teams to ensure test coverage, requirements traceability, defect resolution, and release readiness. Provides technical leadership, mentoring, tool evaluation, exploratory testing, and continuous improvement across software quality engineering practices.

Leads product cybersecurity and privacy activities across development, quality, regulatory, and project teams. Provides threat management, risk assessment, secure SDLC guidance, security requirements, vulnerability investigation, documentation, and customer assurance. Oversees product security deliverables, supports FDA 510(k) submissions, coordinates vendors, and contributes to program planning, agile reviews, design controls, and incident-related activities. The role requires technical leadership, extensive cybersecurity experience, and knowledge of medical device security standards and regulations.

Leads strategic programs and business operations for the COO across global business units and technology centers. Establishes standardized processes, governance, KPI reporting, business reviews, strategic planning, and innovation program management. Coordinates cross-functional stakeholders, supports product portfolio planning, translates complex regulatory and technical topics for executives, and drives organizational alignment. Requires experience in regulated industries, program or operational strategy, P&L management, and global cross-functional leadership. Travel is up to 15%.

Processes customer offers, sales team requests, proposals, pricing approvals, contracts, and deal workflows for Commercial Operations. Advises sales teams on profitable offer structures, ensures compliance with business terms, coordinates with contracting and internal departments, and improves deal-processing efficiency. The role also maintains approval guidelines, templates, checklists, and workflows while supporting negotiations, reporting, and business decision-making.

Supports government and GPO contract strategy through federal opportunity identification, RFP/RFQ analysis, proposal development, contract administration, pricing activations, compliance monitoring, and analytics. Maintains pipelines, dashboards, reports, and contract documentation while coordinating with Sales, Finance, Legal, Marketing, Operations, and other stakeholders. The role focuses primarily on federal government contracts, with approximately 25% GPO responsibilities, including tier changes, pricing alignment, renewals, and performance reporting.