Manufacturing Process Engineer

3 weeks ago

Enfield, Connecticut, United States Cirtec Medical Full time
Job Summary:

This role is 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. The ideal candidate will have a strong background in engineering, with experience in mechanical, tool design, and manufacturing processes, preferably in the medical device industry.

Key Responsibilities:

* Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements, and efficiency from conception to fully established production.
* Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance.
* May help product development with the manufacturing launch of new products, including evaluating yield targets, run rates, training needs, and quality results.
* Prepare engineering change orders and coordinate the deployment of changes, including training Operations team members.
* Perform product and process analysis for cost reduction, quality improvement, and improved efficiency through scrap models and weekly project updates with required actions.
* Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
* Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations.
* Troubleshoot processes when defects occur, help to determine root cause, and implement effective containment and countermeasures.
* Help to lead Non-Conforming Material Report (NCMR) or customer complaint investigations.
* Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing.
* Disposition non-conforming products and develop re-work procedures.
* Communicate with customers regarding process improvements and requested production changes.
* Represent manufacturing on cross-functional teams.
* Attends, schedules, and may lead project meetings to evaluate current and future process initiatives.
* Arrange project meetings with customers to discuss current and future process improvements and development initiatives.

Requirements:

* A bachelor's degree (STEM engineering discipline preferred) and 2 years of experience required; or a combination of education and relevant work experience.
* Experience in an engineering environment with mechanical, tool design, and manufacturing processes, preferably in the medical device industry.
* Willingness to travel, if required.
* Must maintain high ethical standards.
* Must demonstrate good organizational skills.
* Must be able to read, write, and speak fluent English.
* Strong computer skills, including the MS Office suite and MS Project.
* Must be able to fully interpret technical drawings, blueprints, specifications, and illustrations.
* Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
* Ability to learn and apply new technology.
* Technical report preparation and formal presentation skills.

About Cirtec Medical:

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.

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