- 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
- Heart Failure
- Cancer
- Stroke
- Gene Therapy
- COPD
- Traumatic Brain Injury
- Atrial Fibrillation
- Rhinitis
- Back and Neck Pain
- Blood Clots
- Brain Surgery
- +More
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Process Engineer - Lenexa, United States - Vantage MedTech
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Description
As Process Engineer you are 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 process 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 & 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-system. Experience with products containing electronic assemblies is preferred.
Duties & Responsibilities:
Our project list continues to grow and evolve into new therapeutic areas every year. In 2024 we will be developing new products for the treatment of:
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. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, visit
Local candidates only at this time, please. We do not offer relocation assistance.
No third-party candidates please.