Sr Design Assurance Engineer

Responsible for supporting new product development through design assurance, design controls, risk management, and verification & validation methodologies in a regulated environment.

Requirements:

• Bachelor’s or Master’s degree in Engineering, Mathematics, Physics, or related field

• Minimum 5 years of experience in Design Quality Assurance or Product Development Engineering, preferably in medical device development

• Proven experience delivering product quality deliverables in regulated environments

• Strong knowledge of design controls, risk management, and verification & validation methodologies

Preferred Skills:

• Experience with ISO 10555, ISO 80369, and ISO 7864

• Background in new product development processes

• Familiarity with global regulatory standards and quality system requirements

Responsibilities:

• Ensure compliance with design controls and regulatory requirements during product development

• Develop, review, and approve risk management documentation and design assurance deliverables

• Support verification and validation activities, including protocol development, execution, and reporting

• Collaborate with cross-functional teams to resolve design quality issues and ensure product safety and effectiveness

• Provide quality input into new product development processes and continuous improvement initiatives

Pay Details: $40.00 to $54.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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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.