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Actalent is hiring for a Sr Manufacturing Engineer in the Santa Clara area!

Job Description

The Sr Manufacturing Engineer serves as the primary engineering personnel supporting manufacturing operations, including process validation activities. This role requires strong collaboration with the line supervisor, Quality Engineer, and operators to address opportunities on the manufacturing line. The engineer is accountable for quality output and yield and acts as an engineering management representative. Beyond line support, the engineer may also serve as a sustaining engineer for the department, being a subject matter expert in site products and processes.

Responsibilities

+ Own process validation activities, including validation protocols and technical reports.

+ Author, execute, and report on Inspection Method Validations and Test Method Validations.

+ Ensure assigned line output, safety, yield, and quality. Identify product defects and determine operational and process-related actions to reduce defects.

+ Collaborate with line support team, QC supervisor, Manufacturing Supervisor, Quality Engineer, and Operations to perform online issue triage and generate corrective and preventive actions.

+ Possess expert knowledge in statistics, product, and engineering processes.

+ Model/draft assemblies, fixtures, and tools using Solidworks at a mid to advance level.

+ Provide engineering fixes such as tooling and manufacturing aids from idea definition to implementation.

+ Support technicians and supervisors in equipment availability issues.

+ Support and improve the Training and Certification Program.

+ Determine quality impact of Out-of-Tolerance documents.

+ Execute line-related change management, including material, equipment, and process changes.

+ Develop and execute continuous improvement projects, including CAPAs implementations.

+ Evaluate ideas for continuous improvements.

+ Lead root cause analysis for high-complexity manufacturing events and lead CAPA Major investigations.

+ Conduct studies and validations on the line as needed.

+ Represent manufacturing engineering in projects related to yield, CIP's, productivity, quality, and safety.

+ Coordinate product builds through the NPI process.

+ Generate changes to the eLHR system.

+ Lead ME support during external and internal audits.

+ Act as a coach and mentor to less experienced engineers or technical personnel.

+ Lead statistical analysis for complex events at the site.

+ Generate qualification and validation protocols and reports with minimal oversight.

+ Own CR activities with varying complexity with no oversight.

+ Understand regulatory implications of proposed changes and complete documentation to support regulatory filings.

+ Make efficient decisions with minimal oversight and consider risk mitigation in planning.

+ Prepare and contribute to meetings, providing technical guidance to peers.

+ Collaborate with peers across functions internally and externally, with exposure to cross-functional management communications.

+ Lead high-complexity manufacturing engineering projects, including CIPs, CAPA, and Validations.

Essential Skills

+ Minimum 5 years of experience in process validations.

+ Basic knowledge of applicable US and non-US regulations.

+ Proficiency in Manufacturing/Process Engineering principles.

+ Catheter assembly experience.

+ Excellent written, verbal, and interpersonal communication skills.

+ Ability to interact effectively with all levels of employees.

+ Knowledge of common office applications: Word, PowerPoint, Excel.

+ Knowledge of statistical analysis.

+ 3-D drawing skills in Solidworks.

Additional Skills & Qualifications

+ Ability to effectively communicate cross-functionally to resolve Quality/Engineering issues.

Work Environment

The role involves working within a collaborative environment, utilizing various technologies and equipment. The engineer will engage in cross-functional communications and provide technical guidance across teams. The work may require occasional participation in internal and external audits and meetings.

Job Type & Location

This is a Contract position based out of Santa Clara, CA.

Pay and Benefits

The pay range for this position is $55.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 Santa Clara,CA.

Application Deadline

This position is anticipated to close on Nov 21, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.