Werfen · 15 hours ago
Senior Staff Engineer, Hardware
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$175K/yr - $210K/yr
10+ years expWerfen is a growing, family-owned company and a worldwide leader in specialized diagnostics. They are seeking a Senior Staff Mechanical Engineer to provide technical leadership and drive continuous process improvement, focusing on mechanical subsystem ownership and design controls excellence.
Health CareHospitalManufacturingMedical Device
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
Qualification
Required
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
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)
Preferred
M.S. or higher preferred
Experience in Lean and Six Sigma problem-solving methodologies is preferable
Company
Werfen
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
5001-10000 employees
H1B Sponsorship
Werfen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
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