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.