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.

Oversee CAPA and customer complaint processes for medical diagnostic products. Lead investigations, root cause analysis, effectiveness checks, regulatory reporting, audit support, and compliance with FDA, ISO 13485, EU IVDR, and ISO 14971 requirements. Coordinate cross-functional teams, maintain quality metrics, provide training and mentorship, support supplier and risk management, and drive continuous improvement across quality management systems.

Manages R&D product transfer and packaging design activities from development through manufacturing launch. Leads design control, process development, validation, specifications, analytical methods, quality and regulatory compliance, and continuous improvement. Coordinates R&D, manufacturing, operations, QA, RA, QC, and other stakeholders. Oversees investigations, product complaints, nonconformances, CAPA, resource planning, and employee development while ensuring products meet safety, quality, performance, and manufacturability requirements.

Manages clinical applications operations for Werfen’s transfusion diagnostic products across the Southeast and Mid-Atlantic. Leads seven Applications Consultants, overseeing hiring, training, deployment, coaching, customer support, installations, validations, education, regulatory compliance, forecasting, budgets, and revenue growth. Partners with commercial teams to support pre- and post-sales activities and ensure customer satisfaction. Requires clinical or scientific experience, strong leadership and communication skills, and 75% travel.

Provides scientific and technical support for released diagnostic products and collaborates with R&D on new product development, manufacturability, and manufacturing transfer. Applies experimental design and specialized scientific techniques to solve complex problems, develops objectives and plans, documents laboratory work, writes technical reports, communicates progress, and may direct other personnel. Requires hematology expertise, including blood analysis, hematologic data interpretation, and laboratory methodologies. Travel is approximately 10%.

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.

Performs complex verification testing for diagnostic systems, consumables, hardware, software, and assays. Executes protocols, documents results, interprets system requirements against test outcomes, troubleshoots instruments, performs maintenance, prepares serological dilutions, conducts manual testing, identifies processing anomalies, and maintains laboratory spaces. Requires an MLT or MT ASCP certification and a bachelor’s degree or equivalent education and experience.

Leads manufacturing, supply chain, and overall site operations for a regulated diagnostics facility. Oversees production, sourcing, purchasing, warehousing, planning, quality, compliance, safety, budgets, supplier relationships, and audit readiness. Builds high-performing teams, drives continuous improvement, ensures GMP and FDA compliance, manages supply continuity, and coordinates cross-functional initiatives to improve operational efficiency and cost of goods.

Leads architecture, design, implementation, and delivery of complex embedded, connected-device, and application software for regulated medical products. Owns technical decisions, secure connectivity, device management, lifecycle traceability, verification, and software quality. Partners cross-functionally to address risk, cybersecurity, regulatory requirements, and delivery constraints. Mentors engineers, improves engineering practices, resolves architectural issues, and remains hands-on with C/C++, embedded Linux, RTOS, real-time behavior, networking, and software development tools.

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.

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.

Prepares and reviews technical documentation for in vitro diagnostic products, including design history files, regulatory submissions, plans, protocols, reports, and gap analyses. Collaborates with Regulatory Affairs, Quality, Clinical Operations, and Project Management teams to ensure compliance with IVDR, EU MDR, and FDA requirements. Supports audits and regulatory responses, maintains controlled records, identifies documentation improvements, and mentors junior staff.

Reviews, prioritizes, and processes change order submissions across multiple plants and functions. Maintains documentation, bills of materials, drawings, routings, material masters, approved manufacturer lists, and validation protocols. Ensures compliance with documentation standards and quality procedures, supports hazardous-materials screening, manages software submissions, creates SAP BOMs, tracks expired protocols, and assists customers and cross-functional teams with change implementation.

Develops and integrates complex in vitro diagnostic systems throughout the product lifecycle. Responsibilities include defining user and system requirements, decomposing architectures, documenting subsystem requirements, conducting hazard and risk analyses, managing configuration and change control, and driving system integration, optimization, root cause analysis, and testing. The role collaborates with product, engineering, testing, clinical, manufacturing, and external teams, and may provide leadership to a small engineering group.

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.