Process Development Technician I

Cirtec Medical; Enfield (CT); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company match

Job summary

Cirtec Medical in Enfield, Connecticut is seeking a Process Development Technician I, responsible for providing tools and support to engineering and production while adhering to quality and cost requirements.

The ideal candidate will have a high school diploma or GED, 3+ years of experience in medical device manufacturing, and knowledge of FDA and GMP principles. Benefits include competitive compensation, healthcare, and training programs.

Qualifications

• 3+ years' experience in the engineering/manufacturing environment for medical devices.
• Knowledge of FDA, cGMP principles and practices, (ISO 9001, ISO 13485).

Responsibilities

• Identifies, executes and promotes Continuous Improvement objectives.
• Maintain compliance to procedures and regulatory requirements.
• Develop processes and procedures for projects to improve quality and cost.

Skills

Fluent English

Systematic problem solving

Lean Manufacturing

Education

Highschool diploma or General Education Degree (GED)

Tools

Pro-E/CREO

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

Process Development Technician I is primarily responsible for providing tools and support to engineering and production while adhering to quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and 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.

Key Responsibilities

• Identifies, executes and promotes Continuous Improvement objectives
• Assist 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 procedures comprehensive 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

Must Have

• Highschool diploma or General Education Degree (GED) is required
• 3+ years' experience in the engineering/manufacturing environment for medical devices
• FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
• Must be able to read, write and speak fluent English

Good to have

• Familiarity with Pro-E/CREO and SolidWorks
• Demonstrated ability for systematic problem solving, DMAIC
• Excellent reading, writing, communication, and organizational skills.

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.

Benefits

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.