Process Manager

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing 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 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 challenges, you may be a perfect fit for our team!

Key Responsibilities:

• Develop manufacturing processes to meet or exceed product standards under safe conditions and in accordance good manufacturing practices.
• Review product documentation and manufacturing operational documentation to ensure compliance and accuracy. Utilize appropriate systems, procedures and cross functional input to manage revisions to documents, processes and products.
• Coordinate Process team to support overall operations.
• Develop Process Technicians & Process Engineers to further their capabilities and knowledge of our material, molding and secondary processes.
• Through deployment of lean and six-sigma processes responsible for identifying opportunities to improve service, minimize scrap, or otherwise reduce manufacturing costs and improve product quality.
• Provide advanced application and process engineering expertise to facilitate manufacturing efficiencies and continuous improvement
• Plan, design, and coordinate the development and implementation of milling, molding and secondary processes and related quality/engineering activities to support new and existing product development
• Provide responsive support to the manufacturing operation
• Advance the general knowledge of material properties and flashless molding techniques across departmental functions
• Identify and research new processes to support cost reductions, quality improvements, and statistically capable processes
• Ensure documentation is clear, correct, and understandable
• Perform technical support to customers through phone communication, written correspondence, and customer meetings
• Perform technical support to manufacturing, engineering, automation, and maintenance
• Participate in continuous improvement efforts, corrective action formulation, and root-cause investigation

Must Have:

• Bachelors degree in STEM related field required
• Knowledge of cGMP and ability to write and execute IQ/OQ/PQ requirements.
• 5+ years of practical experience in process development in manufacturing and/or applicable manufactured materials.
• Ability to write detailed descriptive correspondence regarding molding processes and other related job responsibilities. Ability to effectively present information in small and large group situations to customers, clients, engineering and management staff, and other employees of the organization.
• Must be able to navigate and use standard Microsoft Office Software (Word, Excel, project, Access, and PowerPoint)
• At least 2 years of Process Management experience

Good to have:

• Preferred Experience:
  
  
  
  • High volume manufacturing experience, working with rubber transfer molding.
  • Six-sigma green belt and/or lean manufacturing certification.
  
  
  
  

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to stand; walk; and talk or hear. The employee will frequently be required to lift and /or move up to 25 pounds and occasionally lifts and/or moves up to 50 pounds. The employee must be able to operate production presses in a manufacturing environment. The employee could come into frequent contact with various types of machine oils, lubricants, and cleaning solvents.

Cirtec Medical Corporation considers 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 of its related companies fully endorse equal opportunity for all. 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 a great 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 career and life stage. 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.