R&D Engineer II

Description

Please note - Sponsorship or transfer of sponsorship, including OPT/F1 Visas, is not available for this role.

Novel Cath a Cirtec company specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets. For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly.

Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

The R&D Engineer II position is primarily responsible for designing, developing catheters, 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.

• 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.

• A Bachelor's degree in a STEM engineering field required
• At least 2 years of experience required in R&D or Process Engineering
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• Previous medical device experience
• Must demonstrate good organizational skills
• Must be able to read, write and speak fluent English
• Strong computer skills, including MS Office
• 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
• Willingness to travel (~5%)

Anticipated salary range: $80000 to 100000/year depending on qualifications and experience.

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.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We…