- 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.
-
Validation Engineer
2 weeks ago
Omega Enterprises Smithton, United StatesMi-Jack Europe GmbH is a leading company in port automation and security. To support our dynamic team, we are currently looking for a Validation Engineer. Your role is crucial for the development, implementation, and monitoring of our quality assurance processes, as well as for t ...
-
Validation Engineer
3 weeks ago
Ingenics Corporation USA Chesterfield, United StatesValidation Engineer · Establish performance and quality criteria · Create and run quality tests based on appropriate protocols · Perform production process validations · Evaluate engineering systems and processes · Calibrate and repair systems and machinery · Prepare and maintain ...
-
Validation Engineer III
1 week ago
Kindeva Drug Delivery St Louis, United StatesKindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we w ...
-
Validation Engineer III VIII
1 week ago
Kindeva Drug Delivery St Louis, United StatesKindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we w ...
-
Verification and Validation Engineer
3 weeks ago
bioMerieux Inc. Hazelwood, United StatesVerification and Validation Engineer · Location: Hazelwood, MO, United States · Position Type: Unfixed Term · Job Function: Engineering · Share: · share to e-mail · Apply Now > · A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagno ...
-
Verification and Validation Engineer
2 weeks ago
BioFire Diagnostics Hazelwood, United StatesBenefits at bioMrieux: · + Low-cost medical, dental, and vision benefits starting day one · + 11 paid holidays · + 160 hours of paid time off · + Annual bonus · + 9.5% 401k company contribution with no vesting period · + Tuition reimbursement up to $10000 per calendar year ...
-
Service Estimator
4 weeks ago
Trane Technologies Fenton, United States Full time: Trane in Fenton, MO is hiring for a Service Estimator II to join our team. In this role, you will be will be working with Trane Account Managers and building owners providing estimates and quotes for HVAC service projects and agreements. Trane always focuses on a total soluti ...
-
Automotive Service Technician
4 weeks ago
RANDY WISE BUICK GMC, INC. Fenton, United StatesAt Randy Wise Auto Group, we strive to make every customer a customer for life. Happy employees make happy customers, and we reward individuals who are ready to work hard and stay motivated. Every employee at Randy Wise Auto Group is absolutely critical to its success. Our promis ...
-
Outside Technical Salesperson
3 days ago
Dynamic Bulk Systems, Inc. Fenton, United StatesJob descriptionNEED: · Outside Technical Sales Representative responsible for selling industrial equipment in an assigned geographic market (no more than 200 miles of St. Louis). Excellent communication skills and mechanical aptitude that can be applied towards learning and subse ...
-
Systems Engineer
1 week ago
BOEING Fenton, MO, United StatesJob Description At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for ...
-
Product Engineer
1 week ago
Control Devices Fenton, United StatesPosition Title: Product Engineer · Department: Engineering · Location: Fenton, MO · Reports To: Director of Product Engineering · Classification: Salary - Exempt · Position Summary: · The primary function of the position is to provide leadership for new product design and d ...
-
Service Estimator
1 week ago
Trane Technologies plc Fenton, United StatesAt Trane TechnologiesTM and through our businesses including Trane and Thermo King, we create innovative climate solutions for buildings, homes, and transportation that challenge what's possible for a sustainable world. We're a team that dares to look at the world's challenges an ...
-
Product Engineer
6 days ago
Control Devices LLC Fenton, United StatesJob Description · Job DescriptionPosition Title: Product Engineer · Department: Engineering · Location: Fenton, MO · Reports To: Director of Product Engineering · Classification: Salary – Exempt · Last Updated: July 2022 · Position Summary: · The primary function of the position ...
-
Senior Analyst Supply Chain
1 week ago
8th Ave Food & Provisions Fenton, United StatesBusiness Unit Description: · 8th Avenue Food & Provisions is a growing organization made up of businesses that produce and sell quality products including pasta, peanut butter, granola, and fruit and nut trail mixes to retail, foodservice and ingredient customers. The company wa ...
-
Land Surveyor/Land Surveyor in Training
1 week ago
Cochran Fenton, United StatesJob Description · Job DescriptionCochran is a growing civil engineering, construction testing, and land surveying firm with 7 offices in Missouri. Cochran specializes in public and private projects including municipal, commercial, residential, transportation, water/wastewater, si ...
-
Pharmaceutical Technician Team Lead
1 week ago
Mallinckrodt Fenton, United StatesJob Title · Pharmaceutical Technician Team Lead · Requisition · JR Pharmaceutical Technician Team Lead (Open) · Location · Fenton, MO (Pharma) - USA040 · Additional Locations · St. Louis, MO · Job Description · SUMMARY OF POSITION: · The Pharmaceutical Technician Team L ...
-
Area General Manager
2 weeks ago
Trane Technologies Fenton, United StatesAt Trane TechnologiesTM and through our businesses including Trane and Thermo King, we create innovative climate solutions for buildings, homes, and transportation that challenge what's possible for a sustainable world. We're a team that dares to look at the world's challenges an ...
-
FSQ Quality Systems Director
1 week ago
8th Ave Food & Provisions Fenton, United StatesBusiness Unit Description: · 8th Avenue Food & Provisions is a growing organization made up of businesses that produce and sell quality products including pasta, peanut butter, granola, and fruit and nut trail mixes to retail, foodservice and ingredient customers. The company wa ...
-
FSQ Quality Systems Director
1 week ago
8th Ave Food & Provisions Fenton, United StatesBusiness Unit Description: · 8th Avenue Food & Provisions is a growing organization made up of businesses that produce and sell quality products including pasta, peanut butter, granola, and fruit and nut trail mixes to retail, foodservice and ingredient customers. The company was ...
-
Ryder System Fenton, United StatesPosition Description · Immediately Hiring a Permanent Full Time Diesel Technician Trainee. This role is Entry Level and DOES NOT REQUIRE Experience to be hired. · We will pay you while training to become a Ryder Diesel Mechanic Technician in Fenton, Missouri.If You're Interested ...
Validation Engineer - Fenton, United States - SIM Surgical
Description
The Validation Engineer at Sim Surgical will be instrumental in ensuring our devices meet all regulatory standards and company requirements. This role will design, execute, and document validation processes to support the development and manufacturing of products such as spinal implants, medical screws, and surgical tools. The role will be critical in maintaining our commitment to delivering safe, reliable, and high-quality medical devices that improve patient outcomes.
Responsibilities:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
