Manufacturing Engineer

3 weeks ago


Irvine, United States Actalent Full time

Job Title: Manufacturing Engineer

For immediate consideration, please apply directly to this job posting AND email habels @actalentservices.com with the following:

  1. Word copy of resume

  2. 2-3 professional references

  3. 4-5 brief bullet points highlighting technical qualifications

Job Description

As a Manufacturing Engineer, you will provide engineering support for existing products and processes, focusing on ongoing improvement activities and projects, including cost and efficiency improvements, capacity increases, and manufacturing line duplications across sites. You will facilitate efficient operations within the production area to optimize existing processes and ensure that production goals are met using lean and six sigma techniques. You will monitor the performance of equipment, machines, and tools, and correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues. You will also interface with New Product Introduction, Quality, and Research and Development organizations in design control projects to integrate new products or processes into the existing manufacturing area.

Responsibilities

  • Provide engineering support for existing products and processes.

  • Engage in ongoing improvement activities and projects including cost and efficiency improvements, capacity increases, and manufacturing line duplications.

  • Facilitate efficient operations within the production area to optimize existing processes.

  • Ensure that production goals are met using lean and six sigma techniques.

  • Monitor the performance of equipment, machines, and tools, and correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.

  • Interface with New Product Introduction, Quality, and Research and Development organizations in design control projects to integrate new products or processes into the existing manufacturing area.

  • Conduct process development, validation, and verification work.

  • Prepare project plans, specifications, and schedules for new product development.

Essential Skills

  • Medical device knowledge

  • Process validation

  • SolidWorks proficiency

  • Class III medical devices experience

  • Manufacturing engineering expertise

  • Fixture and tool design

  • Equipment troubleshooting

  • Production support

  • Research & development

  • Validation and verification

  • Product development engineering

  • Lean manufacturing

  • New Product Introduction (NPI)

Additional Skills & Qualifications

  • Bachelor’s Degree in Engineering or a related field

  • Experience with catheters, balloons, or stents device manufacturing processes and equipment (nice to have)

  • Ability to develop master validation plans to meet FDA and ISO requirements for Class II and Class III devices

  • Knowledge to develop and improve manufacturing processes from concept to implementation including characterization, validation, and cost/capacity analysis

  • Experience with design and process FMEA and translating the associated risk analysis to Process Validation and process control requirements

  • Application of statistical and analytical methods for process development

Work Environment

For 40 years, our organization has been a global leader in the innovation of novel products for the interventional access and treatment of neurovascular diseases. With one of the most comprehensive product portfolios available, our products are used around the world to access and treat multiple disease states, including arterial venous malformations, aneurysms, and ischemic stroke. Our company offers a medium-size company feel with large global company opportunities, exposure to all facets of engineering, cross-functional team interaction, and growth opportunities locally and globally.

Pay and Benefits

The pay range for this position is $45.00 - $48.00

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 Irvine,CA.

Application Deadline

This position will be accepting applications until Jan 30, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.



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