Engineer II, Mechanical - Sensors

Job Summary:

The Engineer II, Mechanical - Sensors is responsible for the design, development, testing, and sustaining of mechanical components and assemblies for patient monitoring sensors and related products. This position applies mechanical engineering principles to develop reliable, manufacturable solutions from concept through production and collaborates cross-functionally to support product performance, quality, regulatory, and manufacturing requirements.

Please note this is a fully on site position in Irvine, CA.

• Design and develop mechanical components, assemblies, and packaging for disposable and reusable patient monitoring sensors and related products.

• Develop 3D CAD models, detailed engineering drawings, specifications, bills of materials, and other design documentation required to support product development and manufacturing.

• Translate product and system requirements into mechanical design requirements and solutions that meet performance, reliability, quality, regulatory, and manufacturing needs.

• Support material selection and design of plastic, metal, elastomeric, adhesive, woven, laminate, and other components used in sensor products.

• Apply design for manufacturability and assembly (DFM/DFA), tolerance analysis, and other engineering methods to optimize designs for performance, quality, cost, and high-volume production.

• Develop prototypes and evaluate design concepts through testing, analysis, and iterative development.

• Develop and execute mechanical test plans, protocols, and reports to support design verification, validation, reliability, environmental, and performance testing.

• Partner with Manufacturing Engineering, Quality, Regulatory, suppliers, and other engineering disciplines to resolve technical issues and support design transfer, production implementation, and sustaining activities.

• Work with suppliers and manufacturing partners to define component and subassembly requirements, address tooling and manufacturability considerations, and resolve design-related issues.

• Participate in design reviews, root cause investigations, product improvement activities, and other cross-functional efforts throughout the product lifecycle.

• 2+ years of mechanical engineering, product development, or related experience, preferably involving electromechanical products or high-volume manufactured products.

• Experience with mechanical product development from requirements and concept development through design, prototyping, testing, and production release.

• Proficiency in 3D CAD modeling and engineering drawings;
  Solid Works experience preferred.

• Working knowledge of mechanical design principles, tolerance analysis, material selection, and design for manufacturability and assembly.

• Experience designing plastic, metal, elastomeric, adhesive, or other mechanical components and assemblies.

• Ability to develop prototypes, conduct engineering testing, analyze results, and document technical findings.

• Strong analytical, problem-solving, organizational, and written and verbal communication skills.

• Ability to manage multiple priorities and work effectively both independently and within cross-functional teams.

• Experience designing disposable or reusable medical device sensors, accessories, or other patient monitoring products.

• Experience with high-volume product design and manufacturing, including plastic injection molding and automated assembly processes.

• Experience with biomedical materials, adhesives, flexible materials, woven or laminate components, and other materials commonly used in sensor applications.

• Knowledge of medical device design controls and applicable FDA, ISO 13485, IEC 60601, UL, ASTM, ISTA, and related standards.

• Experience with mechanical simulation, FEA, stress analysis, rapid prototyping, or related engineering tools and methods.

Bachelor's degree in Mechanical Engineering or a related engineering discipline required

The anticipated salary range for this position is $90,000 - $115,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

• Medical
• Dental
• Vision
• Life/AD&D
• Disability Insurance
• 401(k)
• Vacation
• Sick
• Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• Voluntary Accident
• Critical Illness
• Hospital
• Long-Term Care
• Employee Assistance Program
• Pet Insurance
• On-site wellness clinic
• fitness center
• and cafe

All benefits are subject to eligibility requirements.

• Ability to read, write, and communicate effectively in English.
• Ability to interpret technical documents, schematics, and written instructions.
• Ability to clearly document technical findings and communicate with cross-functional team members.

This position primarily works in a…