Process Development Engineer I

About the job

About The Company

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec 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!

Why should you join Cirtec?

Working at Cirtec is more than a job. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device contract manufacturers. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has exciting opportunities where you can make a difference.

Job Summary

The Engineer I, Process Development is position is primarily responsible for a functional project engineering group within the department, consisting of multiple engineering disciplines. 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
• Track and communicate issues, status on assigned action items that would affect timelines and budget
• Can have responsibility for any of the following project inputs:
  • Feasibility builds, documentation, and testing,
  • Equipment selection,
  • Process development and documentation,
  • Device Verification samples and testing,
  • Operator training,
  • Process Failure Mode Effects Analysis,
  • Clinical builds,
  • Process Validation
• May have involvement in the design, development, and validation requirements of projects, 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.
• Other duties as assigned.

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 Bachelors degree in an engineering discipline and minimum 2 years appropriate work experience;
• Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
• 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 & 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 good small group presentation skills.
• Willingness to travel, if required

What We Offer

• A fast-paced work environment
• 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
• Paid time off
• 401(k) retirement savings with a company match

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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