Design quality engineer - Medical device

Design quality engineer - Medical device at Intellectt, Inc Design quality engineer - Medical device at Intellectt, Inc in Oceanside, California Posted in 2 days ago.

Type:

full-time

Job Description:

Job Title:

Design Quality Engineer (Medical Device)

Location:

Carlsbad, CA (100% Onsite)

Duration:

12

Months Contract Summary :

We are seeking an experienced Design Quality Engineer to support critical design quality initiatives for an electromechanical medical device product line. This role will focus on design change assessments, risk management activities, design validation support, CAPA investigations, and quality system improvements within a regulated environment. The ideal candidate will have hands-on experience supporting electromechanical medical devices, strong problem-solving skills, and expertise in design quality, risk management, and quality investigations while collaborating with cross-functional teams throughout the product lifecycle .

Key Responsibilities:

Support design quality activities for electromechanical medical device products. Lead and support design change assessments and change order activities. Develop and maintain risk management documentation. Support design verification and validation activities. Lead CAPA investigations, root cause analysis, and corrective actions. Investigate product issues, field failures, and quality-related events. Collaborate with Engineering, Manufacturing, Regulatory, and Quality teams. Author technical reports and quality documentation. Ensure compliance with internal quality systems and regulatory requirements. Support continuous improvement initiatives.

Required Qualifications:

Bachelor's degree in Engineering or a related technical discipline. Experience working within a regulated Medical Device environment. Hands-on experience with CAPA ownership, investigations, and root cause analysis. Experience supporting design change assessments and risk management documentation. Experience working with electromechanical products. Strong analytical, problem-solving, and communication skills.

Preferred Qualifications:

Experience supporting design validation activities Experience authoring technical reports and documentation. Exposure to field failure investigations and associated quality process. Knowledge of Medical Device quality systems and regulatory requirements.