1 Validation Engineer Job in FENTON, MO
SIM Surgical is Hiring a Validation Engineer Near FENTON, MO
- Develop and implement validation plans for new and existing products, considering design, manufacturing processes, equipment, and software in compliance with FDA regulations and ISO standards.
- Coordinate with Engineering, manufacturing, and quality teams to establish requirements and standards for validation activities.
- Execute validation tests including but not limited to design validation, process validation, software validation, and test method validation.
- Prepare, review, and approve validation documents, including protocols, reports, and risk assessments.
- Ensure that all validation activities are conducted in accordance with internal procedures and regulatory requirements.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Provide technical support for troubleshooting and resolving validation issues encountered during production or testing.
- Stay current with industry standards, regulatory requirements, and advancements in technology and apply them to validation practices.
- Collaborate with cross-functional teams to facilitate changes or improvements in manufacturing processes, product design, and quality assurance methods.
- Assist in the development and implementation of training programs related to validation processes and procedures.
- Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
- Minimum of 3 years of experience in validation engineering within the medical device industry.
- In-depth knowledge of FDA regulations, including QSR and ISO 13485, as well as other international standards relevant to medical device manufacturing.
- Strong understanding of validation principles, including design, process, and software validation.
- Experience with statistical analysis tools and methodologies.
- Excellent problem-solving, analytical, and organizational skills.
- Strong communication and teamwork skills, with the ability to work effectively in cross-functional teams.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Moderate noise levels typical of a manufacturing setting.
- Regular requirement to sit, talk, and hear.
- Frequent need to walk; use hands for fine manipulation, handle objects, and reach.
- Occasional requirement to stand, climb, balance, stoop, kneel, crouch, or crawl.
- Occasionally lift and/or move objects up to 25 pounds.
- Increased time spent in an office setting for data analysis, meetings, and administrative tasks.
- Frequent use of computers and office equipment.
- Potential travel to other company locations, suppliers, customers, or industry events.
Job Summary
Full Time
Medical Technology
$54k-73k (estimate)
03/29/2024
06/25/2024
simsurgical.com
FENTON, MO
25 - 50
1968
WILLIAM BARTLING
$5M - $10M
Medical Technology
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About SIM Surgical
Founded in 1968 and located in Fenton, Missouri, SIM Surgical has emerged as a leading provider of contract manufacturing solutions to customers in search of the best medical device manufacturers. SIM Surgical was built on a new business model for contract-manufacturing one based on hand craftsmanship and innovation supported by production processes designed to move your instruments or devices from concept to volume production in a fast and cost effective manner. As part of our dedication to product quality, processes, and delivery, we take pride in our equipment and the capabilities which th...at equipment provides. We maintain world class machining centers to manufacture a broad variety of surgical instruments and implants. Our facility houses all departments in one site for quick and convenient contact within our organization. We serve the following specialty markets: Arthroscopy Spine Interventional spine Trauma Small joint Large joint Dental Extremities Opthalmic
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The job skills required for Validation Engineer include Problem Solving, Teamwork, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer positions, which can be used as a reference in future career path planning. As a Validation Engineer, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer. You can explore the career advancement for a Validation Engineer below and select your interested title to get hiring information.
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