Process Engineer

3 weeks ago

Lenexa, Kansas, United States Vantage MedTech Full time

Vantage MedTech is seeking a skilled Process Engineer to join our team. As a key member of our Engineering and Manufacturing teams, you will be responsible for ensuring the successful transition of innovative designs 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 our 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 creating, updating, and ensuring compliance with robust manufacturing processes, adhering to company standards, ISO, and GMP requirements. Additionally, you will drive improvement projects that impact quality and productivity.

This role requires demonstrated leadership capability and proven knowledge of design for manufacturability & assembly, product manufacturing processes & qualification, 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 preferred.

Responsibilities:

  • Provide technical leadership throughout the product design process regarding design for manufacturability and manufacturing process development
  • Coordinate 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

Requirements:

  • 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

Vantage MedTech offers great benefits, competitive salary, and generous paid time off. We provide comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization.

Partnering with the world's most innovative MedTech start-ups and large OEMs, we offer feasibility support, product development and prototyping, clinical and commercial manufacturing, and after-market services to support every phase of the product life cycle.

Vantage MedTech has offices in Moonachie, New Jersey, and Lenexa, Kansas. Our project list continues to grow and evolve into new therapeutic areas every year.

We are developing new products for the treatment of heart failure, cancer, stroke, gene therapy, COPD, traumatic brain injury, atrial fibrillation, rhinitis, back and neck pain, blood clots, and brain surgery.

We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide.

Vantage MedTech values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.

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