Validation Engineer-Medical

Actuant Corporation - Cortland, NY (30+ days ago)3.3

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Actuant Corporation is a $1.2B diversified industrial company serving customers from operations in more than 30 countries. The Actuant businesses are leaders in a broad array of niche markets including branded hydraulic tools and solutions; specialized products and services for energy markets and highly engineered position and motion control systems. The Company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin. Actuant business operations are divided into three segments focused on the markets we serve. For more information visit

Cortland is a global designer and manufacturer of engineered synthetic ropes, heavy lift slings, electro-optical-mechanical cables, and umbilicals. We have, throughout all of our facilities, the broadest collection of rope and cable processing capabilities available anywhere. With a history of entrepreneurialism and a broad experience in custom-built applications, we deliver world-class solutions that maximize performance, safety, and efficiency for our clients in the oil and gas, heavy marine, subsea, ROV, seismic, defense, and medical markets. From our strategically placed sales, engineering, and service centers, we support global customers at a local level. We are proud of our commitment to drive performance and provide continuous improvements for our clients.

Job Title:
Validation Engineer

Job Location:
Cortland, NY

Business Contribution:
The Validation Engineer position is integral to the success of our growing Medical business; contributions of the position include the development of validation processes and documentation in support of New Product Development (NPD) and Legacy Product activity. This individual will work within company procedures to maintain Design History Files (DHFs) and Device Master Records (DMRs) in a compliant manner that supports and promotes the Quality Management System (QMS). The incumbent will be expected to take a lead role in the verification of new product design, qualification of new equipment and validation of processes and software. Integral team member in Risk Management activities, that ensure process risk is identified, and incorporated into the applicable validation activity. The Validation Engineer will develop Master Validation Plans (MVPs) in support of NPD activity and maintain a Master Validation Schedule (MVS) for the Validation and re-validation of processes and software. In addition, they will actively lead and participate in Cortland’s Safety Management System and Cortland’s LEAD System and initiatives for Continuous Improvement.

Key Responsibilities:
Establish validation procedures, forms and templates in compliance with the requirements of the QMS
Maintain DHFs and DMRs in a compliant manner that supports and promotes the QMS
Responsible for generating all verification, qualification and validation protocols, conducting statistical analysis of data and generating the final engineering report
Member of the NPD team and responsible for the verification of new product design and the validation of new processes and software
Establish and implement MVPs in support of NPD design transfer activity and other validation needs as required
Assist process development by establishing and implementing Designed Experiments (DOEs) that allow for the optimization of process
Responsible for facility, utility and equipment installation qualifications (EIQs) and equipment operational qualifications (EOQs)
Responsible for Measurement System Analysis (MSA) studies (i.e. GR&R), Operational Qualification (OQ) and Performance Qualification (PQ) in support of process development, engineering change control and design transfer activity
Establish and maintain a MVS in support of the qualification, validation and re-validation of equipment, processes and software
Support Risk Management activities, which ensure process risk is identified, and incorporated into the applicable validation activity

Key Relationships:
The Validation Engineer will be the go-to person for verification, qualification and validation activity in support of process development, change management and design transfer activity and will work closely with:
Quality Assurance
Process Engineering
Applications Engineering
Production Personnel
Production Supervisors
Required Capabilities (describe scope of knowledge and ability of the position):

AAS Degree required; BS in Engineering preferred
Five or more years’ relevant work experience required
Demonstrated experience using statistical techniques, such as Hypothesis Testing, GR&R, Correlation, Capability Analysis, Design of Experiment and Statistical Sampling preferred
Experience in an ISO 9001 and/or ISO 13485 manufacturing environment preferred
Green Belt Certification preferred
If you’re looking for a unique, exciting career with variety and potential for growth, Actuant offers challenges & extraordinary rewards for people on a global scale. Choose opportunity – choose Actuant

EEO/AA (W/M/Vets/Disability) Employer

  • LI-JH1
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Required Experience