Description
About us:
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!
Position Summary:
The NPI Engineer (New Product and Process Introduction) is primarily responsible for supporting the design, development, documentation, and validation of new customer and/ or transfer products within a cross-functional engineering team. This role involves contributing to product and process development activities, including design verification, testing builds, and manufacturing transfer preparation.
The role also includes assisting with modifications to existing products, including defining requirements, timelines, and deliverables. With a focus on hands-on learning, the NPI Engineer, will gain exposure and lead key engineering processes, process validation strategies, and manufacturing workflows, while ensuring compliance with quality standards.
The position emphasizes collaboration with cross-functional teams, customers, and suppliers to support the successful execution of engineering projects. This level II role requires experience on transfers as part of and/or leading teams from the sending site to the receiving site, including the use of soft skills as tools to support a smooth transition from site to site.
Key Responsibilities:
- Support, participate and lead (as necessary) project meetings to discuss current and future product transfers and development initiatives, collaborating closely with cross-functional teams.
- Assist and/or lead customer communication for projects.
- Develop and maintain project plans to meet milestones, deadlines, budgets, and required quality regulations, ensuring all actions are tracked and communicated effectively.
- Contribute to establishing plans for project status reporting, issue resolution, action item tracking, budget alignment, and timeline management.
- Collaborate with colleagues to troubleshoot production processes, applying technical support skills while learning core engineering and manufacturing practices.
- Assist in evaluating and recommending appropriate test methods for specific product design requirements.
- Specific Project Inputs
- Provide support for essential project tasks, including:
- Feasibility builds, documentation, and testing
- Process development and equipment evaluation
- Operator training
- Process Failure Mode and Effects Analysis (PFMEA)
- Process validation activities
- Design, Development, and Validation
- Participate in design, development, and validation efforts across the project lifecycle, including:
- Product design and specification creation for assemblies, materials, and packaging.
- Supporting fixturing prototyping and materials sourcing
- Assisting in design verification and validation activities
- Supporting developing and leading manufacturing transfer activities, including production readiness and documentation
- Ensure reliable, punctual, and consistent attendance as an essential function of the role.
- Work in compliance with company, quality, and safety standards, policies, and procedures always.
- Perform other duties as assigned to support project engineering goals and milestones.
This is not a remote position.
Must Have:
- Bachelor’s degree in a STEM-related engineering discipline (Mechanical, Manufacturing, Biomedical, or similar required).
- 3 to 5years of relevant engineering experience, including co-op positions, Manufacturing Engineering experience, NPI and or transfer experience as team member or leader during a product/process transfer and/or development.
- Fully understanding engineering principles, technical writing, material properties, and process development. Willingness to learn more advanced concepts, including tooling practices and statistics, is essential.
- Familiarity with project principles and concepts is required.
- Experience with manufacturing processes (design validation, prototyping, process development) medical device experience is required.
- Ability to learn and interpret technical drawings, blueprints, specifications, and written instructions under mentorship.
- Proficiency in common software tools, including MS Office (Excel, Word, PowerPoint, Microsoft Project) and project tracking tools. Familiarity with CAD and design tools is advantageous.
- Strong organizational and time-management skills, with the ability to prioritize effectively and communicate clearly.
- Ethical behavior and adherence to company policies and quality standards.
- Demonstrates eagerness to learn and apply new technology and engineering practices.
- High level of English.
- Passport and Visa are required.
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.