Senior Manufacturing Engineer

The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. Project will be focused on validating (IQ, OQ, PQ) of equipment.
This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.

Job Responsibilities:
* Expert knowledge of Installation, Operational and Performance Qualification (IQ, OQ, PQ) of complex systems and equipment
* Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
* Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
* Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
* Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
* Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
* Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
* Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
* Evaluate data and write reports to validate or indicate deviations from existing standards.

Skills:
* Creativity, verbal and written communication skills, analytical and problem solving ability.
* Team player and detail oriented.
* Ability to make sketches, engineering drawings and common computations.
* Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
* Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Must-Have Requirements:
* Hands-on experience with IQ, OQ, and PQ execution
* Experience in medical device validation
* Ability to clearly explain validation concepts (IQ/OQ/PQ)
* Ability to work independently with minimal ramp-up

Nice-to-Have:
* Prior experience in Medical Devices or similar environments
* Experience as a repeat contractor in regulated environments
* Exposure to software validation within equipment systems

Soft Skills:
* Strong communication skills
* Ability to collaborate across teams
* Comfortable in fast-paced, high-priority environments
* Not siloed; team-oriented approach

Top Candidate Indicators:
* Can hit the ground running
* Requires minimal guidance
* Quickly understands project scope
* Demonstrates deep validation experience

Education/Experience:
* Bachelor's degree in engineering required.
* 5-7 years experience required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.