Post Market Surveillance Engineer (Contract) - 21491

Job Description

Job Description

Post Market Surveillance Engineer (Contract) - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Post Market Surveillance Engineer (Contract) in Aliso Viejo, CA who possesses:

• Bachelor's degree in Engineering required; Biomedical Engineering preferred
• 1+ year of professional industry experience involving risk management, complaint handling, quality investigations, and/or post-market compliance
• Experience performing investigations, root cause analysis, and technical documentation within a regulated quality environment
• Strong understanding of engineering problem-solving methodologies
• Ability to manage multiple investigations and priorities while maintaining accurate documentation
• Medical device experience strongly preferred; ophthalmic experience is a plus

FULL DESCRIPTION: We are seeking a Post Market Surveillance Engineer for an approximately four-month contract assignment supporting post-market complaint investigation activities for a medical device organization in Aliso Viejo, CA. This role will primarily focus on complaint investigation, root cause analysis, risk assessment, technical documentation, and cross-functional coordination related to an ophthalmic medical device product. The ideal candidate will have an Engineering degree and at least one year of meaningful professional experience within medical device Quality, Post Market Surveillance, Product Quality, or a related regulated environment. This is primarily a desk-based engineering and quality role with limited hands-on testing responsibilities.

The selected candidate will be responsible for:

• Supporting post-market surveillance and complaint-handling activities for medical device products
• Conducting technical investigations related to product complaints
• Reviewing complaint information and determining appropriate investigation pathways
• Performing root cause analysis using established engineering problem-solving methodologies
• Evaluating product issues and available evidence to determine potential failure mechanisms
• Documenting investigation activities, findings, conclusions, and supporting rationale
• Maintaining clear and accurate technical documentation in accordance with quality-system requirements
• Supporting risk-management activities related to product complaints and post-market performance
• Evaluating complaint trends and recurring product-quality issues
• Coordinating with Quality, Engineering, Manufacturing, Clinical, Regulatory, and other cross-functional groups as appropriate
• Gathering information from internal stakeholders to support complaint investigations
• Following investigations through completion and ensuring required documentation is finalized
• Managing multiple complaint investigations and competing priorities simultaneously
• Escalating potentially significant product-quality or compliance concerns as appropriate
• Supporting analysis of returned or complaint-related product when necessary
• Performing limited visual and microscopic evaluation of devices as needed
• Supporting limited functional testing of non-electromechanical devices when required
• Interpreting technical information and translating investigation findings into clear written conclusions
• Applying engineering judgment to product-quality and complaint-related issues
• Supporting continuous improvement of complaint-investigation and post-market surveillance processes
• Maintaining compliance with applicable quality procedures and documentation standards
• Performing other Post Market Surveillance and Product Quality responsibilities as assigned

The selected candidate will also possess:

• Bachelor's degree in Engineering required
• Biomedical Engineering degree preferred
• 1+ year of relevant professional industry experience required
• Candidates with only academic experience or short-term internships will generally not meet the experience requirement
• Medical device industry experience strongly preferred
• Post Market Surveillance experience preferred, but not required
• Complaint-handling experience strongly preferred
• Quality Assurance or Product Quality experience may be considered in place of direct Post Market Surveillance experience
• Product Quality Analyst experience may be applicable
• Experience investigating product or equipment failures required
• Root cause analysis experience required
• Risk-management experience preferred
• Technical documentation experience required
• Experience working within regulated quality-system processes strongly preferred
• Experience coordinating investigations across multiple departments preferred
• Ability to independently evaluate information and identify appropriate next steps
• Understanding of engineering problem-solving methodologies required
• Strong analytical and investigative skills required
• Strong technical writing skills required
• Excellent attention to detail required
• Strong organization and documentation skills required
• Ability to manage multiple priorities and investigations simultaneously
• Ability to communicate effectively with Engineering, Quality, Manufacturing, Regulatory, and other cross-functional teams
• Experience with ophthalmic products preferred, but not required
• Experience supporting ophthalmic medical devices or related healthcare technology a plus
• Previous experience in biomedical technology environments, including hospital biomedical equipment support, may be considered when accompanied by the required Engineering degree and applicable investigation experience
• Extensive bench-testing experience is not required
• Ability to perform occasional visual, microscopic, and basic functional product evaluations as needed
• Ability to work onsite in Aliso Viejo, CA
• Ability to work Monday through Friday approximately 8:00 AM to 5:00 PM
• Ability to support an approximately four-month temporary assignment
• Potential longer-term opportunities may exist based on future business needs, but are not guaranteed
• No employment sponsorship available
• Ability to successfully complete a required background check

Physical Requirements:

• Ability to sit and work at a computer for extended periods while reviewing complaints, investigation records, technical documentation, quality-system information, and engineering data
• Ability to use hands and fingers for typing, documentation, data entry, and standard office tasks
• Ability to review technical documents, device records, investigation data, photographs, and computer screens for extended periods
• Ability to communicate by phone, email, virtual meeting, and in person throughout the workday
• Ability to occasionally perform visual or microscopic inspection of medical devices or components
• Ability to occasionally perform light functional testing or handle complaint-related devices as required
• Ability to occasionally stand, walk, bend, and reach within office or light laboratory environments
• Ability to maintain accuracy, organization, confidentiality, and attention to detail while managing multiple investigations and compliance-related responsibilities

Salary Range: $38 to $43/hour
More information can be found at .

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Company Description

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.