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Process Development Engineer I
3 months ago
This position is eligible for a $5,000 sign on bonus. 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 I, Process Development is primarily responsible for a functional project engineering group within the department, consisting of multiple engineering disciplines. They are 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. 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: o Feasibility builds, documentation, and testing o Equipment selection o Process development and documentation o Device Verification samples and testing o Operator training o Process Failure Mode Effects Analysis o Clinical builds o Process Validation • May have involvement in the design, development, and validation requirements of projects, including: o Product design and specification creation, including mechanical and electrical components, assemblies, and packaging o Materials sourcing and device prototyping o Design verification and validation activities, including data for regulatory submission o Manufacturing transfer and support of existing product lines as applicable • 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 • Bachelor’s Degree required with 0 years of experience, or a combination of education and relevant 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. • Ability to work on life saving products. • 401(k) retirement savings with a company match. • 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. • Clean, and well-lit production areas. 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. #J-18808-Ljbffr
