Job Title: Senior Manufacturing Engineer

Location: Sunnyvale, California

Our client is a leading medical device manufacturing company dedicated to improving patient outcomes through innovative solutions. They're committed to excellence, quality, and continuous improvement in all aspects of our work.

Job Description:

We are seeking a highly skilled and experienced Senior Manufacturing Engineer. The ideal candidate will have a strong background in fixture design, tooling design, and equipment design, with a focus on new product introduction (NPI), validation, and regulatory requirements. This role will involve extensive documentation, equipment repair, and bill of materials (BOM) management. Proficiency in CAD, SolidWorks, and Six Sigma methodologies is essential.

Key Responsibilities:

• Design and develop fixtures, tooling, and equipment for manufacturing processes.

• Lead new product introduction (NPI) projects, ensuring timely and successful product launches.

• Conduct validation and verification activities to meet regulatory requirements.

• Create and maintain detailed documentation for all manufacturing processes and equipment.

• Perform equipment repair and maintenance to ensure optimal performance.

• Manage and update bill of materials (BOM) for all products.

• Utilize CAD and SolidWorks for design and development tasks.

• Implement Six Sigma and ISO 13485 standards to improve process efficiency and product quality.

• Develop and improve manufacturing processes, focusing on laser welding, micro-welding, and reliability testing.

• Collaborate with cross-functional teams to drive process development and improvement initiatives.

  Qualifications:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field.

• Minimum of 5 years of experience in a manufacturing engineering role, preferably in the medical device industry.

• Proficiency in CAD and SolidWorks.

• Strong knowledge of Six Sigma methodologies and ISO 13485 standards.

• Experience with fixture design, tooling design, and equipment design.

• Familiarity with laser welding, micro-welding, and reliability testing.

• Excellent problem-solving skills and attention to detail.

• Strong communication and documentation skills.

• Ability to work effectively in a team environment and manage multiple projects simultaneously.

Skills:

Fixture Design, tooling design, equipment design, NPI, Validation, Regulatory requirements, Documentation, equipment repair, BOM, Medical Device, CAD, solidworks, six sigma, 13485, Process Development, Process Improvement, Laser, laser welding, micro-welding, reliability testing

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.