Senior Mechanical Engineer – New Product Development (Medical Devices)

Intellectt Inc; Dublin (CA); On-site; USD 120,000 - 130,000; Full time

Job summary

Intellectt Inc is seeking a Senior Mechanical Engineer with strong experience in medical device NPD and electromechanical product development. The engineer will provide technical leadership from concept through prototyping, verification, design freeze, and production release.

You will lead mechanical design for electromechanical devices, own architecture, enclosures, thermal management, and EMI/EMC considerations, and collaborate with cross-functional teams to ensure regulatory compliance and

Qualifications

• Bachelor's or Master's in Mechanical Engineering.
• 8–12 years in mechanical design and development.
• Experience with electromechanical integration and thermal design.
• Proficient in SolidWorks or Creo.
• Knowledge of GD&T, ASME Y14.5, FEA.
• Experience with regulated product development (DHF, dFMEA/pFMEA).

Responsibilities

• Lead development of electromechanical medical devices.
• Own mechanical architecture, enclosures, mechanisms, mounts, thermal management, EMI/EMC.
• Create 3D CAD models, drawings, BOMs, GD&T.
• Integrate motors, sensors, PCBs, batteries, connectors, and cabling.
• Lead DFM/DFA, FMEA, risk analysis, and design reviews.
• Support EVT, DVT, V&V, FAI, PPAP, and design transfer.
• Support ECO/ECN, NCRs, deviations, and manufacturing issue resolution.
• Work with suppliers and cross-functional teams including Electrical, Software, Systems, Quality, Regulatory, and Manufacturing.
• Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR 820, and IEC standards.

Skills

Technical leadership

Cross-functional collaboration

Problem solving

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Creo

Windchill

Agile

Job description

Salary:

The Salary range for this position is $120K - $130K/Annum, depending on experience and qualifications.

Benefits:

Benefits will be provided by the hiring client in accordance with their policies.

Job Summary:

We are seeking a Senior Mechanical Engineer with strong experience in medical device NPD and electromechanical product development. The engineer will provide technical leadership for mechanical design from concept through prototyping, verification, design freeze, and production release.

Key Responsibilities:

• Lead mechanical design and development of electromechanical medical devices.
• Own mechanical architecture, enclosures, mechanisms, mounts, thermal management, cable routing, and EMI/EMC considerations.
• Develop 3D CAD models, detailed drawings, BOMs, GD&T, and tolerance stack-ups.
• Integrate motors, sensors, PCBs, batteries, connectors, and cabling.
• Lead DFM/DFA, FMEA, risk analysis, and design reviews.
• Support EVT, DVT, V&V, FAI, PPAP, pilot builds, and design transfer.
• Support ECO/ECN, NCRs, deviations, and manufacturing issue resolution.
• Work with suppliers and cross-functional teams including Electrical, Software, Systems, Quality, Regulatory, and Manufacturing.
• Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR 820, and applicable IEC standards.
• Perform FEA, engineering calculations, and reliability/tolerance analysis.
• Mentor junior engineers and provide technical leadership.

Requirements:

• Bachelor's or Master's degree in Mechanical Engineering.
• 8–12 years of mechanical design and product development experience.
• Strong experience with SolidWorks or Creo.
• Strong knowledge of GD&T / ASME Y14.5, tolerance stack-up, DFM/DFA, and FEA.
• Experience with electromechanical integration, thermal design, and EMI/EMC considerations.
• Experience with DHF, dFMEA/pFMEA, design controls, verification/validation, and regulated product development.
• Experience with PLM/QMS tools such as Windchill or Agile preferred.
• Strong technical leadership and cross-functional communication skills.

Equal Opportunity Employer:

• We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
• Background checks may be conducted in accordance with applicable laws.

Work Authorization:

• Applicants must be authorized to work in the United States