Senior Staff Engineer, Hardware

DescriptionResponsible for the resolution of production process issues utilizing problem-solving tec h niques 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 prod uc tion 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 .Additional Skills & QualificationsStrong 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 M echanical E ngineering 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.Job Type & LocationThis is a Permanent position based out of San Diego, CA.Pay and BenefitsThe pay range for this position is $175000.00 - $210000.00/yr.Full benefits available: medical, dental, 401K, etcWorkplace TypeThis is a fully onsite position in San Diego,CA.Application DeadlineThis position is anticipated to close on Mar 9, 2026.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email () for other accommodation options.

Created: 2026-03-04