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Process Engineer

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Kansas (USA), United States

Offer summary

Qualifications:

BS or MS in Mechanical or Manufacturing Engineering, 1-3 years experience in medical device manufacturing, Knowledge of cGMP and ISO 13485.

Key responsabilities:

Provide technical leadership in design manufacturability
Coordinate transfer of designs to manufacturing
Establish manufacturing specifications and documentation
Support training of manufacturing personnel
Identify and drive process improvements

Vantage MedTech SME https://vantagemedtech.com/

201 - 500 Employees

See more Vantage MedTech offers

Job description

The Process 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 & 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.

**This is not a remote opportunity. This position is based Lenexa, KS. Local candidates only at this time. We do not offer relocation assistance.

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

Education and Experience

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.

Vantage MedTech provides 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
Brain Surgery
+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!

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 www.vantagemedtech.com

Local candidates only at this time, please. We do not offer relocation assistance.
No third-party candidates please.