OverviewPosition SummaryWerfen 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 annual base salary range for this role is currently $175,000 to $210,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
ResponsibilitiesKey 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.
QualificationsSkills & 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 tools (AI, 3D CAD, drawing standards, PDM/PLM, test/measurement methods; analysis tools such as FEA are a plus).
Minimum Knowledge & Experience Required for the Position- 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.
