Sr. Manufacturing Engineer

About the role

Cirtec Medical has been a leading outsourcing partner for complex medical devices since 1990. We specialize in comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our teams prioritize growth, innovation, and collaboration.

Responsibilities

• Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements, and efficiency
• Document processes and implement creative ideas or solutions to improve assembly operations, including development of tooling/fixturing as needed
• Help product development with the manufacturing launch of new products, including evaluating yield targets, run rates, training needs, and quality results
• Prepare engineering change orders and coordinate the deployment of changes, including training Operations team members
• Perform product and process analysis for cost reduction, quality improvement, and improved efficiency
• Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions
• Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations
• Troubleshoot processes when defects occur, help determine root cause, and implement effective containment and countermeasures
• Participate in Material Review Board (MRB) and lead Non-Conforming Material Report (NCMR) or customer complaint investigations
• Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing
• Disposition non-conforming products and develop re-work procedures
• Communicate with customers regarding process improvements and requested production changes
• Represent manufacturing on cross-functional teams
• Participate in Kaizens and drive improvement efforts

Requirements

• A Bachelor’s degree in a STEM engineering discipline
• 5 years of experience required in a Manufacturing Engineering role
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
• Advanced knowledge of manufacturing and assembly processes
• Previous experience with the ability to direct, lead, and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support, and tooling
• Excellent verbal and written communication skills
• The capacity to work well under pressure, change priorities on the fly, and take on new challenges
• Project management skills and the ability to work to tight deadlines
• Teamwork and people management skills
• Experience associated with continuous improvement activities like participation in Kaizen events using lean manufacturing principles
• A practical and logical approach to problem-solving using lean six sigma concepts
• Willingness to travel if required

Must have

• Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred

Salary Range

$100,000 to $128,000 based on experience