Description:

• Provide manufacturing engineering support for the successful implementation of new or revised processes into production, including the preparation of process procedures and specifications, training of operating and service personnel, and continuing monitoring and troubleshooting, as needed.
• Develop and maintain laser weld & laser mark processes and equipment used in the production operations.
• Write protocols for and perform Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for production tools and processes.
• Use the Cadence Engineering Change Notice (ECN) processes to implement process documentation changes to support production.
• Participate in Design for Manufacturability (DFM) analysis of new products, including recommendations/cost analysis for design improvements.
• Interact with customers as the SME for manufacturing process and equipment.

Lead assigned Continuous Improvement projects.

Use proactive methods (statistical process control, failure modes effects analysis, etc.) to look for production/facilities problems before they happen.

Own CAPA (Corrective Action/Preventative Action) projects to apply long term corrections to process issues.

• Champion the use of Good Manufacturing Practices (GMP) in manufacturing Cadence medical products.
• Train production operators in process changes and good manufacturing practices.
• Partner with Production Supervisor to drive employee safety improvements and adherence.
• Actively look for safety issues that would affect employees and customers.

Additional Skills & Qualifications:

• Bachelor's degree in engineering with at least 3-5 years' experience performing tasks described above.
• Engineering expertise in assembly, packaging and related manufacturing processes.
• Strong experience in project management/leading projects for manufacturing areas.
• Willingness and ability to work onsite.
• Demonstrated ability to serve as a SME for manufacturing processes and equipment to both customers and internal project teams.
• Experience in medical device manufacturing environment with FDA and ISO13485 is a plus.
• Ability to interact effectively with management and employees.

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 for other accommodation options.