Mechanical Engineer

Job Title: Mechanical Engineer
Location: Los Angeles, CA (Company Confidential)

Role Overview:
A Medical Device Company in Los Angeles is advancing next‑generation medical technologies that improve patient outcomes through thoughtful engineering and human-centered design. We’re seeking a Mechanical Engineer with 3–5 years of experience to own end-to-end design activities, from concept through manufacturing, for electromechanical and implantable/portable medical devices. You’ll collaborate closely with electrical, firmware, quality, and clinical teams to deliver robust, manufacturable designs under a regulated quality system.

Key responsibilities

Lead mechanical design from concept to production: architecture, detailed CAD, drawings, tolerances, and materials selection.
Develop mechanisms, enclosures, and precision assemblies for compact electromechanical systems; perform stack-ups and DFM/DFA tradeoffs.
Build and iterate prototypes (rapid prototyping, soft tooling), plan benchtop experiments, and analyze results to drive design decisions.
Conduct engineering analyses (tolerance, structural, thermal, fatigue, vibration) using first principles and CAE where appropriate.
Create documentation: specifications, test methods, BOMs, drawings with GD&T, and ECOs within PLM.
Partner with suppliers and contract manufacturers on process capability, tooling, and cost/quality improvements.
Execute verification and validation activities: test plans, fixtures, data analysis, and reports; support risk management (DFMEA).
Contribute to design reviews and cross-functional problem solving; track actions to closure.
Support transfer to manufacturing, including pilot builds, root-cause analysis, CAPA input, and sustaining engineering.

Minimum qualifications

BS in Mechanical Engineering or related field.
3–5 years of hands-on mechanical design experience for complex electromechanical products.
Proficiency in 3D CAD (e.g., SolidWorks, Creo, or NX) and creating production-ready drawings with GD&T.
Demonstrated DFM/DFA experience and collaboration with suppliers/manufacturers.
Strong fundamentals in mechanics of materials, kinematics, and thermals; ability to run quick hand calcs and targeted FEA.
Experience with prototyping methods (machining, 3D printing, sheet metal, injection molding) and test fixture development.
Clear, concise technical communication and documentation skills.

Preferred Qualifications

MS in Mechanical Engineering.
Experience in medical devices or other regulated industries (ISO 13485, FDA QSR, IEC 60601, ISO 10993 awareness).
Background in micro-mechanisms, wearables, or implantable device packaging; sealing, sterilization, and biocompatible materials.
Familiarity with risk management (ISO 14971), usability (IEC 62366), and design controls.
Experience with reliability testing (HALT/HASS), environmental testing, and statistical analysis (GR&R, DOE).

Success Indicators

Delivers designs that meet requirements on performance, reliability, cost, and schedule.
Clean design history and test documentation that withstands internal and external audits.
Smooth supplier handoffs with minimal late-cycle changes; measurable improvement in yield/quality.
Prototypes that inform decisions quickly, with data-driven iteration.
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