Description

•\tCollaborate with Systems Engineers, Operations, Quality, Regulatory, design teams to analyze existing product documentation (G7, Stelo) and identify gaps in requirements traceability all the way to manufacturing.

•\tDevelop and maintain comprehensive traceability matrices linking design inputs, design outputs, and manufacturing processes.

•\tDefine and document manufacturing requirements based on design requirements, specifications and performance criteria.

•\tParticipate in design reviews and provide input on manufacturability and testability.

•\tSupport the development of process control plans and inspection procedures.

•\tIdentify and propose solutions to address gaps and inconsistencies in requirements and processes.

•\tWork with cross-functional teams (design, manufacturing, quality) to ensure alignment on requirements and processes.

•\tProvide training and guidance to other team members on requirements management and traceability best practices.

Skills

INCOSE Systems Engineering Handbook, requirements writing, manufacturing process controls, Jame Connect, product development lifecycle, statistical analysis, data interpretation, medical device development, ISO 13485, FDA 21 CFR Part 820

Additional Skills & Qualifications

Experience with hardware testing equipment is a plus, specifically related to CGM devices. Understanding of hardware architecture, interface specifications, and system-level design.CSEP (Certified Systems Engineering Professional) or ASEP (Associate Systems Engineering Professional) preferred.

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in San Diego,CA.

Application Deadline

This position is anticipated to close on Feb 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.