Description:

This position is responsible for optimizing the manufacturability of products. Responsibilities include design, develop, and validate manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

• Provide technical leadership, training, mentorship to engineers and technicians.

• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures, which are consistent with a zero defect level as well as low product cost.

• Perform process validation activities on manufacturing processes.

• Develop and provide ”Design for Manufacturability” data for new products, based on actual experience of previous products. Develop effective action plans to avoid and resolve manufacturing issues.

• Collaborate with Product Development Teams to ensure effective design transfer of new products into the manufacturing plant.

• Create and maintain tooling drawings and shop orders in coordination with the Quality Assurance and R&D functions.

• Coordinate work of assigned technicians and temporary workers as needed.

• Plan and schedule projects in a manner consistent with corporate objectives.

• Maintain accurate documentation of concepts, designs, and processes.

• Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.

• Participate in facilities engineering and planning when appropriate.

• Ensure GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions. Accurate and timely completion of manufacturing

documentation including manufacturing procedures, material records, etc.

• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

• Performs other duties as may be required by management.

Skills:

Manufacturing engineering, Medical device, design for manufacturing, Validation, supplier management

Additional Skills & Qualifications:

• Experience with the medical device industry, manufacturing Class II/III medical devices, specifically with cardiac pacemaker leads or catheters.

• Knowledge of FDA requirements as they relate to manufacturing

• Experience with establishing and supporting manufacturing processes such as manual assembly, medical device packaging and labeling, resistance spot or laser welding, or injection molding or extrusion.

• Project Management training and experience.

• Lean/Six Sigma Black Belt Certified

• Experience with implementation of Lean Sigma concepts

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.