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Cirtec Medical Process Development Technician II in Enfield, Connecticut

Process Development Technician II

Department: Development Engineering

Location: Enfield, CT

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This position is located on-site based out of Enfield, CT.

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today-s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers- devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

You are a part of:

The Engineering team consists of engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

JOB SUMMARY

The Technician II, Process Development 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 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 and performs at an advanced level.

ESSENTIAL 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 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

  • 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

  • Reliable, consistent, and punctual attendance is an essential function of the job

  • Other Duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities

listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform

the essential functions of this position.

QUALIFICATIONS

  • Bachelor-s degree in related technical field

  • 3 Plus years- experience in the engineering/manufacturing environment for medical devices

  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)

  • Experience with Silicone molding is a plus

  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.

  • Strong computer skills associated with Microsoft software

  • Ability to interpret technical drawing, blueprints, specification, and illustrations

  • Must be able to read, write and speak fluent English.

  • Excellent reading, writing, communication, and organizational skills.

  • Demonstrated ability for systematic problem solving, DMAIC

WHAT WE OFFER

  • A fast-paced work environment

  • Paid time off

  • 401(k) retirement savings with a company match

  • Clean, and well-lit production areas

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate.

The work environment characteristics described here are representative of those an individual encounters

while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with

Disabilities/Protected Veteran and Affirmative Action Employer

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.

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