Manufacturing Engineer

Immediate Manufacturing Engineering Opportunity

For Immediate Consideration Please Apply directly to this posting and email your resume to ~~~

Description

Production support of catheters and consoles including subassemblies, final devise, packaging, testing, and manufacturing.

• Completion of NMR and CAPA investigations, corrective actions, implementation, and resolutions.

• Establishing equipment preventive maintenance, calibration criteria, writing and executing equipment qualifications.

• Experience with tools such as multimeters, oscilloscope, power supply, microscope, thermal traversers, packing sealers, and tensile tester.

• Ability to read, develop, and understand mechanical drawings, specifications, electronics schematics, and flowcharts.

• Supports end of life component changes, identifying and qualifying alternate components, and changes to assure continuous uneventful production is maintained.

• Familiarity with ISO and FDA regulations

• Updating manufacturing documents including work instructions, production travelers, inspection procedure, and standard operating procedure.

• Manage production documentation, ensuring documentation and processes are aligned, updating for process improvements, working with production staff to incorporate changes, completing document change notifications, and training for the updates.

• Work with Research and Development new product and process development, production transfer, project plan activities, and nonconformance investigations.

• Performing product development activities that could include new or modified designs for new or existing products and document changes of optical, opto-mechanical, electro-optical modules, systems, and instruments.

• Identify opportunities for production equipment, fixtures, and tooling improvements.

• Maintains product and company reputation by complying with government regulations.

• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.

• Participates in team meetings, provides feedback about manufacturing, process improvements.

Skills

Manufacturing engineering, fda, process improvement, class iii medical devices

Top Skills Details

Manufacturing engineering,fda,process improvement

Additional Skills & Qualifications:

College graduate with BS in Manufacturing, Industrial, Biomedical, Electrical, or Mechanical Engineering

• 3-5 years of medical device manufacturing engineering experience.

• Medical device development and product transfer experience is a plus

• Skilled in using Microsoft programs, ERP systems, Solidworks, and electronic documentation software.

• Must be fully trained and possess demonstrated ability to meet established standards in the manufacturing processes established for this specific area.

• Familiarity with quality control system in a Good Manufacturing Practices (GMP) environment is required.

Experience Level

Intermediate Level

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 ~~~ (~~~) for other accommodation options.