Description
NPI Engineer
Location: Lenexa, KS
Job Title: NPI EngineerLocation: Lenexa, KS
Department: New Product Introduction
Reports to: Director of NPI
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We are developing and manufacturing new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!
The NPI (New Product Introduction) Engineer will be responsible for ensuring that our innovative designs are transitioned into effective and sustainable production. Our life saving products are manufactured in Kansas City and require predictable delivery of high quality, cost-effective production over 5+ year product lifetimes. You will collaborate with Vantage MedTech’s Engineering and Manufacturing teams to provide input on the device design’s manufacturability, and plan and execute the transfer of these new products to our manufacturing facility. You will be responsible for ensuring that robust manufacturing processes are created, updated and in compliance with company standards, ISO, and GMP as required. In addition, you will help drive improvement projects that impact quality and productivity.
This role requires demonstrated leadership capability and proven knowledge of design for manufacturability and assembly, product manufacturing processes, qualifications, and the transfer of new designs into manufacturing. Many of our products involve the assembly of electronic, software, and mechanical sub-systems. Experience with products containing electronic assemblies is highly preferred.
**This is not a remote opportunity. This position is based in Lenexa, KS. Candidate must either be local or willing to re-locate to the Kansas City metro area. Vantage MedTech does not offer relocation assistance at this time.
Key Responsibilities:
- Provide technical leadership throughout the product design process regarding design for manufacturability and manufacturing process development.
- Provide coordination between engineering and manufacturing in transferring designs to manufacturing for commercial and clinical study devices.
- Provide on-site support for production and pre-production builds in engineering and manufacturing.
- Establish initial manufacturing specifications, procedures, and associated documentation.
- Assist with the specification, purchase and development of equipment, tools, and fixtures to support product transfer to manufacturing.
- Plan and execute installation, operational, and performance qualification activities related to the successful transfer of product to manufacturing.
- Assist with training of manufacturing personnel.
- Identify and drive process improvements to improve quality and productivity.
- BS or MS degree in Engineering, preferably Mechanical or Manufacturing Engineering.
- Minimum of 1- 3 years of experience in a medical device or manufacturing environment.
- Knowledge of cGMP, ISO 13485 and production requirements.
- Excellent communication skills with the ability to present technical information and prepare written reports.
- Proven ability to analyze complex systems and break them down into a series of clear and organized parts.
- Ability to work effectively in a team environment and build relationships at multiple organizational levels.
- Ability to successfully manage and implement projects.
- Demonstrated ability to troubleshoot and identify opportunities for improvement.
As a team member at Vantage MedTech, you’ll enjoy:
- Comprehensive benefits package, including health, vision, and dental insurance.
- Generous Paid Time Off.
- Company retirement plan with matching.
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