Manufacturing Engineer II

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Position Summary:

This position is primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods in accordance with customer product specifications for components and assemblies to Class III medical device quality standards. Manufacturing Engineers document processes and could implement ideas or solutions to improve assembly operations which may include development of tooling/fixturing as needed to accomplish this task.

Key Responsibilities:

• Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
• Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
• Execute continuous improvement projects for cost reduction, Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
• Develop and qualify various tools and equipment required for manufacturing processes.
• Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
• Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
• Supporting required equipment qualification and process validations (IQ, OQ and PQ).
• Troubleshoot manufacturing processes when defects occur. Determine root cause and implement effective containment and countermeasures.
• Help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and production changes.
• Represent manufacturing on cross functional teams.
• Participate in Kaizen events and drive continuous improvement efforts.
• Complies with company, quality and safety standards, policies, and procedures
• Attends and schedules project meetings to determine current and future process initiatives.
• Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing
• Arrange project meetings with customers to discuss current and future process improvements and development initiatives.

Must Have:

• A Bachelors degree in an engineering discipline or related field required
• Minimum 3+ years of engineering experience in a Medical manufacturing environment, or equivalent
• Strong knowledge of manufacturing and assembly processes
• Excellent verbal and written communication skills
• Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
• Experience with supporting documents including, MS Project, ECN's, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
• Experience with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
• Interpersonal, presentation and communication skills.
• The capacity to work well under pressure and take on new challenges.
• Organizational and time management skills.
• Project management skills and the ability to work to tight deadlines
• Willingness to travel, if required
• Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
• Technical report preparation and formal presentation skills

Good to have:

• Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
• Experience with mechanical, tool design, and manufacturing processes preferred

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.