Process Development Technician II

Cirtec Medical; Enfield (CT); On-site; USD 44,000 - 48,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off and 401(k) retirement

Competitive compensation plans

Job summary

Cirtec Medical in Enfield, CT is seeking a Process Development Technician II to support engineering and production under GMP and ISO standards. You will develop tools, write procedures, and help drive cost and quality improvements across medical device projects.

You will collaborate with cross functional teams, prepare engineering change orders, and ensure compliance with safety and regulatory requirements while applying DMAIC and Lean principles to reduce waste and improve processes.

Qualifications

• High school diploma or GED required.
• 3+ years in engineering/manufacturing for medical devices.
• Familiar with FDA, cGMP, ISO 9001/13485.
• Proficient with Microsoft Office software.
• Ability to read and interpret technical drawings and blueprints.
• Prior process development experience in a medical device environment.

Responsibilities

• Identify and promote Continuous Improvement objectives.
• Assist in defining Lean Manufacturing requirements.
• Develop processes and procedures to improve quality and cost.
• Originate and maintain written technical descriptions of processes and procedures.
• Represent engineering in Material Review Board discussions and cross functional teams.
• Maintain compliance to procedures and regulatory requirements.
• Follow safety policies, attend training, and wear PPE as required.
• Prepare project plans to satisfy timeline requirements.
• Prepare Engineering Change Orders for processes and components.
• Perform Corrective and Preventative Action tasks.

Skills

DMAIC

Process development

Blueprint reading

Microsoft Office

Cross-functional collaboration

Education

High school diploma or GED

Tools

Creo / Pro-E

SolidWorks

Job description

Description

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!

Position Summary:

The Process Development Technician II is primarily responsible for providing tools and support to engineering and production while adhering to the quality and cost requirements of the company.The tools included but are not limited to written processes and procedures, equipment, fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed and performs at an advanced level.

Key Responsibilities:

• Identifies, executes, and promotes Continuous Improvement objectives
• Assists in defining Lean Manufacturing requirements
• Develop processes and procedures for projects to improve quality and cost
• Originate and maintain written technical descriptions of processes and procedurescomprehensive in scope and understandable by the audience
• Represent engineering for Material Review Board concerning material dispositions
• Represent Engineering in cross functional teams as assigned
• Maintain compliance to procedures and regulatory requirements
• Understand and follow safety policies and practices, attend safety training and wear PPE as required
• Maintains and prepares project plans to satisfy timeline requirements
• Prepares Engineering Change Orders for processes and components
• Performs Corrective and Preventative Action tasks

Must Have:

• High school diploma or GED
• 3 Plus years' experience in the engineering/manufacturing environment for medical devices
• FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
• Strong computer skills associated with Microsoft software
• Ability to interpret technical drawing, blueprints, specification, and illustrations
• Prior process development experience in a medical device environment

Good to have:

• Experience with Silicone molding is a plus
• Familiarity with Pro-E / CREO and or SolidWorks is preferred.
• Must be able to read, write and speak fluent English.
• Excellent reading, writing, communication, and organizational skills.
• Demonstrated ability for systematic problem solving, DMAIC.

Salary Range: $31.95 to $35.00 per hour.

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.

• 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
• Competitive compensation plans designed to support you at every career and life stage