Senior Staff Engineer, Hardware

Werfen•San Diego, CA

4h•$175,000 - $210,000

About The Position

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.

Requirements

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 tools (AI, 3D CAD, drawing standards, PDM/PLM, test/measurement methods; analysis tools such as FEA are a plus).
Bachelor’s degree in Mechanical Engineering or related discipline required (M.S. or higher preferred).
Typically, 10+ years of progressive mechanical engineering experience with multiple full product development cycles; medical device and/or regulated product development strongly preferred.
Significant experience owning subsystem or product-level mechanical scope through V&V and design transfer into manufacturing.
Experience with consumables-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., ISO 13485, 21 CFR 820, and risk management practices aligned with ISO 14971).

Nice To Haves

Experience in Lean and Six Sigma problem-solving methodologies is preferable.

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.
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.