Process Development Engineer II

Description

About us: For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components. 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 challenge, you may be a perfect fit for our team! Position Summary: The Process Development Engineer II 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. Key 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
• Complies with company, quality and safety standards, policies, and procedures

This is not a remote position. Must Have:

• Bachelor's of Science Degree in a STEM discipline 
• 2+ years of experience in Process Engineering required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• Must maintain high ethical standards
• 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, if required

Good to have:

• Previous Medical Device Experience

Competitive market salary from $80000 to 95000 per year depending on qualifications and experience. 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. 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 an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.