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Senior Staff Mechanical Engineer

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werfen

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Location:
United States , San Diego

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

175000.00 - 210000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

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

Nice to have:

  • M.S. or higher degree
  • medical device and/or regulated product development experience
  • Experience with consumables-relevant manufacturing processes
  • Experience in Lean and Six Sigma problem-solving methodologies
  • Analysis tools such as FEA

Additional Information:

Job Posted:
February 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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