Senior Staff Engineer, Hardware

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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 $175000 and $210000 per year depending on experience.

Key Responsibilities:

• Responsible for the resolution of production process issuesutilizingproblem-solving techniques to analyzeidentifyroot cause(s)developand 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 andmaintainhigh-quality design inputs/outputs DHF documentation DFMEA/PFMEA verification evidence and change records compliant withWerfenQMS 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 andvalidatematerials and processesappropriate forconsumables (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 orparticipatein Lean Six Sigma projects of significant scope and complexity.

Networking/Key relationships

• Builds strong working relationships withSystems EngineeringandAssayDevelopment.
• 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.

Skills & Capabilities:

• Strong engineering fundamentals ininjection molding processesplastic weldingprecision 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 tradeoffsbalancingperformance reliability schedule cost and risk.
• Excellent written and verbal communication skills; able to produce clear audit-ready documentation and concise executive-ready updates.
• Proficiencywith modern mechanical engineering tools (AI 3D CAD drawing standards PDM/PLM test/measurement methods; analysis tools such as FEA are a plus).

Minimum Knowledge & Experiencefor the position:

• Bachelors degreeinMechanicalEngineeringor related discipline(M.S.or higherpreferred).
• Typically 10 years of progressive mechanical engineering experience with multiple full product development cycles; medical device and/or regulated product developmentstronglypreferred.
• Significant experienceowningsubsystemor product-level mechanical scope through V&V and design transfer into manufacturing.
• Experience withconsumables-relevant manufacturing processes strongly desired (e.g. injection molding film/lamination handling ultrasonic/thermal welding adhesives sealing technologies precision assembly).
• Working knowledge of regulated development expectations (e.g. ISOCFR 820 and risk management practices aligned with ISO 14971).
• Experience in Lean and Six Sigma problem-solving methodologies is preferable.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.