Design Assurance Engineer

Support design controls, risk management, verification and validation, and regulatory compliance activities for Class II electromechanical medical devices.

Job Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field

• Three to five years of experience supporting engineering and development of Class II electromechanical medical devices

• Experience with medical device design controls

• Experience with risk management activities

• Experience developing or maintaining DFMEA and PFMEA documentation

• Experience supporting design verification and validation activities

• Experience with process validation, including IQ, OQ, and PQ

• Experience supporting software validation

• Experience maintaining Design History Files and technical documentation

• Experience preparing design specifications and verification/validation protocols

• Knowledge of FDA Quality System requirements

• Knowledge of ISO 13485 and ISO 14971

• Proficiency with Microsoft Word and Excel

Preferred Skills

• Bachelor’s degree in Electrical Engineering

• Knowledge of IEC 60601

• Knowledge of IEC 60825

• Knowledge of IEC 62366

• Knowledge of IEC 62304

• Experience supporting EMC, EMI, IEC, or related product compliance testing

• Experience working with third-party test laboratories such as TÜV or Intertek

• Experience supporting FDA, CE, or other regulatory submissions

• Experience with Minitab

• Knowledge of hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance interval analysis, and sample-size determination

• Experience with lasers or optical technologies

Job Responsibilities

• Conduct design control activities for new product development and sustaining engineering projects

• Support design and process risk analysis

• Develop and maintain DFMEA and PFMEA documentation

• Support design verification and validation activities

• Support software validation activities

• Develop and execute process validation activities, including IQ, OQ, and PQ

• Support creation and maintenance of Design History Files and technical files

• Develop and maintain design specifications and verification/validation protocols

• Coordinate product compliance testing with external test laboratories

• Support EMC, EMI, IEC, and related regulatory testing

• Assist with FDA, CE, and other regulatory submissions

• Apply applicable medical device regulations and standards to product development activities

• Perform statistical analysis to support validation, verification, and quality engineering activities

• Maintain technical and quality documentation throughout the product lifecycle

Pay: 90k-95k/year

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $90,000.00 to $95,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.