Senior Staff Engineer, Hardware

Introduction

Werfen

 

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

 

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary:

Werfen is seeking a Senior Staff Mechanical Engineer to provide technical leadership and continuous process improvement.  This role is a senior-level individual contributor position responsible for defining and driving process improvement, detailed design, and technical decision-making from feasibility through verification/validation, design transfer, and lifecycle support. The Senior Staff Mechanical Engineer is expected to operate with a high degree of autonomy and raise the technical bar through robust engineering practices and disciplined design control execution. 

 

The pay range for this role is between $175,000 and $210,000 per year, depending on experience.

Responsibilities

Key Responsibilities:

• Responsible for the resolution of production process issues utilizing problem-solving techniques to analyze, identify root cause(s), develop and implement solutions. 
• Technical Ownership (Consumable Mechanical Subsystem): Serve as the mechanical technical owner for consumable assemblies and interfaces, ensuring end-to-end production process performance, reliability, manufacturability, and cost targets. 
• Design Controls Excellence: Author and maintain high-quality design inputs/outputs, DHF documentation, DFMEA/PFMEA, verification evidence, and change records compliant with Werfen QMS and applicable standards. 
• Drive DFM/DFA, tooling strategy, and manufacturing readiness activities; partner with Operations and suppliers to ensure scalable high-volume production and robust process windows. 
• Materials/Process Selection for Consumables: Select and validate materials and processes appropriate for consumables (polymers, films, adhesives, seals, welded joints). 
• Verification, Test Methods & Fixtures: Define verification strategy, develop test methods, fixtures, gage strategies, and data analysis to support traceable verification conclusions. 
• Lifecycle/Sustaining Support: Lead investigations and resolution of field/manufacturing issues (RCA, CAPA support, design changes), ensuring effective improvements are implemented. 
• May lead or participate in Lean Six Sigma projects of significant scope and complexity. 

 

Networking/Key relationships 

• Builds strong working relationships with Systems Engineering and Assay Development. 
• Quality / Regulatory: Supplier Quality, Quality Engineering, Regulatory Affairs (support for technical documentation and compliance). 
• Operations: Manufacturing Engineering, NPI/Design Transfer, Production, Packaging Engineering, Supply Chain/Procurement. 
• External: Key suppliers/contract manufacturers (tooling, molding, assembly, materials), metrology labs, and test partners. 

 

Qualifications

Skills & Capabilities: 

• Strong engineering fundamentals in injection molding processes, plastic welding, precision mechanical design, tolerance analysis, GD&T, materials selection, failure analysis, and robustness engineering. 
• Deep experience applying DFM/DFA for high-volume manufacturing; automation, tooling strategy and ramp support. 
• Proven ability to translate requirements into design solutions and deliver traceable verification evidence within a design controls framework. 
• Strong problem-solving methods (structured RCA, hypothesis-driven experimentation, statistical thinking) with a record of closing complex issues. 
• Comfortable leading cross-functional technical reviews and making sound tradeoffs balancing performance, reliability, schedule, cost, and risk. 
• Excellent written and verbal communication skills; able to produce clear, audit-ready documentation and concise executive-ready updates. 
• Proficiency with modern mechanical engineering tool