Validation Engineer

Job 2597 - Validation Engineer - Contract located near Minneapolis, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Mid-Career Engineer supporting our Validation Engineer with Attribute Test Method validations (creating samples, executing protocols, writing reports). Work may expand into Process Risk Assessments and drafting Process Characterization Reports for Commercial Test Methods.

• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing on complex projects to ensure project success.
• Consistently generates innovative and unique solutions to meet department goals.
• Successfully completes complex engineering work and contributes to new product development team and product support typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma process study, process improvements and report preparation.
• Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• Summarizes, analyzes and draws conclusions from complex test results.
• Designs and prepares complex reports and communicates results to the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Leads in the identification, implementation and management of production goals.
• Trains, develops and/or provides work direction to operators, technicians and engineers.

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• 5 years of experience with BS in engineering, Mechanical, Chemical, Bio Med.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

Sponsorship is not available for this position.

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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.