Staff Engineer, Instrument Manufacturing

Werfen•San Diego, CA

About The Position

The Staff Manufacturing Engineer applies advanced technical insight, hands-on experience, and deep knowledge of electrical systems to support complex Manufacturing Engineering activities focused on instrument electronics and printed circuit board assemblies (PCBAs) in the instrument area. This role is responsible for solving multifaceted issues in new product design transfer, manufacturing process development and optimization for medical diagnostic instruments, electrical integration, sustaining engineering, and daily production operations. The Staff Manufacturing Engineer will lead cross-functional teams on continuous improvement projects, develop and execute validation protocols and final reports, and drive manufacturing activities to ensure high-yield, reliable production of complex electromechanical instruments.

Requirements

Bachelor’s degree (Mechanical or Electrical Engineering) or equivalent years of experience; advanced degree a plus.
Eight (10) to ten (15) years previous manufacturing engineering experience preferred; previous experience within a regulated medical device or pharmaceutical environment strongly preferred.
Strong Electrical Engineering background with deep proficiency in electrical schematics, BOM management, and electromechanical instrument integration.
In-depth knowledge of instrument electronics and PCBA technologies, including sustaining support, integration, and technical oversight of contract manufacturers.
Excellent troubleshooting and root-cause analysis skills for electrical and instrument-level failures in a production/CM environment.
Expertise in writing and performing validations in a GMP and ISO9001 regulated environment. This also includes URS/FAT for new equipment acquisition.
Strong working knowledge of statistical tools including Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis (Cp/Cpk), and sampling plans to support validation and quality control.
Thorough understanding of FDA 21 CFR Part 820, GMP, ISO 13485, and OSHA regulations, with demonstrated experience supporting regulatory audits.
Excellent communication, organizational, and time management skills; ability to pay close attention to detail.
Excellent technical writing, verbal communication, and cross-functional leadership skills with the ability to clearly convey complex electrical and manufacturing concepts.
Good leadership ability with experience coordinating and providing technical guidance to external CMs/vendors.
Able to travel to visit vendors processes.

Nice To Haves

Six Sigma Green Belt or Black Belt methodology a plus.

Responsibilities

Function as a lead team member for design control project teams; ensure design requirements are met and comply with applicable standards.
Work as a lead project team member to complete all activities needed to conclude projects per plans.
Develop and implement process controls for new products and for transfer to manufacturing.
Develop statistically based sampling plans for design verification, design and process validation activities, new/existing product test methods, and incoming inspection to ensure they meet their predetermined requirements.
Oversee validation project teams; prepare agendas, issue meeting minutes, and participate in development of quality plans.
Write, review, and approve validations (installation qualification IQ/operational qualification OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards.
Function as an advanced support resource; lead training initiatives of department staff as directed.
Provide statistical analysis of process and test data to support validation reports and continuous improvement.
Ensure all projects/processes are following FDA, Good Manufacturing Practices (GMP), Quality System Requirement (QSR), ISO-13485:2003 and other applicable requirements.
Actively participate in FDA inspections, ISO audits, and internal/customer audits as a subject matter expert on instrument electronics.
Provide cross-functional support by delivering required technical documentation and data to meet compliance needs.
Identify and implement opportunities for continuous improvement in Instrument yield, cycle time, and first-pass quality.
Coordinate activities with cross-functional departments, external CMs/vendors, and customers.
Maintain fiscal responsibility and budget compliance.
Ensure and maintain compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes.
Other duties as assigned.