- Innovative Product Design: Spearhead the development and verification of catheter designs, ensuring they meet rigorous medical standards and patient needs. Utilize advanced engineering principles to create effective, reliable, and innovative solutions.
- Design for Manufacture: Develop and refine the design to enable efficient product flow and high yields. This includes the selection and design of equipment, tooling, and fixture, to enhance catheter production and testing. Conduct DOE and Gage R&D, as appropriate to dial in the right process settings.
- Create Documentation: Generate details documentation, including work instructions, test methods, and visual guidelines, to standardize manufacturing processes.
- Collaborative Problem-solving: Work closely with a cross-functional team to identify root causes of product nonconformances. Develop and implement corrective and preventative actions, leveraging your expertise to troubleshoot and refine processes.
- Manufacturing Transition Support: Collaborate with quality and operations teams to ensure smooth transition of products to manufacturing. Provide critical Design for Manufacturing (DFM) input throughout the product development lifecycle to ensure products are optimized for manufacturing.
- Education and Training: Train and guide support staff in the proper execution of manufacturing processes and the use of specialized tooling and fixtures, ensuring adherence to best practices and quality standards.
- All other duties as required
- Bachelor's degree in Mechanical, Biomedical, or other relevant Engineering required
- Minimum 3 years working in a catheter development and manufacturing environment, with a focus on product and process design
- Demonstrated excellent written and oral communication skills
- A working knowledge of minimally invasive medical device design, development, and manufacturing processes
- Understanding of process validation (IQ, OQ, PQ) strategy
- Excellent working knowledge of GD&T and Solidworks
- Working knowledge of Minitab
- Experience with design controls, FDA regulation, GMP, GDP, and QMS requirements
- Must be able to work with a microscope and sit/stand for an extended period of time
- Must be able to lift 50 lbs
- Working knowledge of Six Sigma
- Experience with lean manufacturing processes
- Experience in defining budgets and schedules for projects
- Understanding of machining principles and schedules for projects
- Comprehensive, Low Cost Health and Dental Insurance Plans Available
- Vision Insurance
- Health Savings Account with company contribution
- Short and Long Term Disability
- Supplemental insurances (short term disability, AD&D, life insurance, and more)
- Paid Time Off
- Paid Holidays
- 401K with company match
- Competitive compensation
- Opportunities for career growth and advancement
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R&D Engineer II - Minneapolis, United States - Vital Path
Description
Join VitalPath in New Hope as a R&D Engineer IIAbout VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We're excited about this important work and bring vital energy to our customer partnerships. In our growing organization it's important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people's lives and be a part of a friendly, fun place to work with people that value diversity, come join our team
About the Position
At VitalPath, the role of a Research and Development Engineer II is central to our mission of pioneering medical technology. Your expertise will be paramount in orchestrating the design and development of our customers' products and associated manufacturing processes. This role is tailored for those passionate about merging innovative design with practical application, ensuring our products not only meet but excel beyond our and our customers' design specifications and performance criteria.
Responsibilities