Responsibilities:

Conduct hazard analysis and risk assessments for medical device and therapeutic products

Support CAPA investigations and quality system escalations

Prepare and maintain technical documentation and reports

Perform post-market complaint tracking, trending, and analysis

Collaborate with cross-functional teams including Medical Safety, Design Assurance, Return Product Analysis, Supplier Development, and Manufacturing

Apply applied statistics and data analysis to evaluate quality and safety issues

Ensure compliance with quality system processes and regulatory requirements

Requirements:

Bachelor’s degree in Biomedical Engineering, Mathematics, Chemical Engineering, or related field

1–3 years of relevant experience

Understanding of engineering topics and applied statistics

Experience operating within quality system processes and procedures

Ability to manage project work independently and meet delivery timelines

Preferred Skills:

Engineering degree with 2+ years of relevant medical device experience

Strong technical understanding of medical device therapy products

Experience with hazard analysis and risk assessment for trend management

Strong technical writing skills for quality and regulatory documentation

Experience with CAPA investigations, field assessments, and quality system escalations

Knowledge of regulatory requirements for post-market surveillance in medical devices

Pay Details: $33.00 to $37.00 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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan 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.