Process Development Engineer II

Cirtec Medical; Enfield (CT); On-site; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Process Development Engineer to join their dynamic team in Enfield, CT. This role involves designing and qualifying manufacturing processes for medical devices, collaborating with cross-functional teams, and ensuring compliance with quality standards. The ideal candidate will have a background in mechanical engineering and experience in manufacturing processes. If you thrive in a fast-paced environment and are passionate about advancing medical technology, this position offers a unique opportunity to make a significant impact in the industry.

Benefits

Paid Time Off

401(k) Retirement Savings with Company Match

Training and Career Development

Health Care Programs

Clean and Well-Lit Production Areas

Qualifications

• Bachelor's degree in STEM engineering discipline with 2 years of experience required.
• Experience in mechanical design and manufacturing processes preferred.

Responsibilities

• Design, develop, and qualify manufacturing processes for medical devices.
• Collaborate with teams to ensure project timelines and budgets are met.

Skills

Mechanical Engineering

Tool Design

Manufacturing Processes

Statistical Analysis

Technical Report Preparation

Analytical Skills

Education

Bachelor’s Degree in Engineering

Tools

Minitab

Job description

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 Engineer II, Process Development position is primarily responsible for designing, developing, and

qualifying manufacturing processes, consisting of multiple engineering disciplines, for the manufacture of

medical devices. The position will be involved in the design, development, documentation, and validation

and 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.

ESSENTIAL RESPONSIBILITIES

• Attends and arranges project meetings to discuss current and future design and development initiatives.
• Serve as a primary contact with customers on programs of low to moderate complexity and serve as secondary contact with customers on programs of moderate to high complexity.
• Track and communicate the status of assigned action items that would affect timelines and budgets.
• Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
• Assist in the preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Provide input to program management for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
• Responsible for the following project inputs : Feasibility builds, documentation, root cause analysis, and testing, Equipment selection and qualification, Process development and documentation, Device Verification samples and testing, Operator training, Process Failure Mode Effects Analysis, Clinical builds, Process Validation.
• Involvement in the full design, development, and validation requirements of programs, including : Product design and specification creation, including mechanical and electrical components, assemblies, and packaging, Materials sourcing and device prototyping, Design verification and validation activities, including data for regulatory submission, Manufacturing transfer and support of existing product lines as applicable.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Complies with company, quality and safety standards, policies, and procedures
• 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

• 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 (medical device preferred)
• 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
• Experience with Minitab and statistical analysis
• Experience with documented change control processes.
• Must be able to fully interpret technical drawings, blueprints, specifications & 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

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.