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Product Evaluations Engineer I
Location:
Wheat Ridge, CO
Description:
Biomedical Device Consultants & Laboratories ( www.bdclabs.com ) is a fast-growing company that offers comprehensive medical device testing services, design verification test equipment, and silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding. BDC Labs is seeking a Product Evaluations Engineer I who has the overall responsibility for preparation and execution of studies, reporting of study results and to maintain / ensure compliance with applicable standards and company quality system requirements. Position Description & Responsibilities: Ensures equipment is adequately calibrated, inspected, cleaned, and maintained prior to use in a All reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration Support development of protocols, test methods, and validation Functions performed are clearly understood and conducted in accordance with the approved Ensuring all data generated during the conduct of a laboratory study, except those that are generated by automated data collection systems, are recorded directly, promptly, and All data entries are dated on the date of entry and signed or initialed by the person entering the data and all procedures for data recording / documentation or followed. All experimental data, including observations of unanticipated responses of the test system are accurately recorded and All raw data, documentation, protocols, final reports, and specimens (as appropriate) generated as a result of a laboratory study are Perform data analysis and create software scripts and templates to perform data Unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, and corrective action is taken and Prepares final reports for each laboratory study and the project deliverables are met and the final study report accurately describes the methods and procedures, and that the reported results accurately reflect the raw data of the laboratory study. Manages projects in order to keep them on schedule, within scope, within budget all while providing good customer Participate in regulatory inspection activities with regulatory agencies, as Practices Value Stream Mapping (VSM) and 5S Qualifications: Minimum of a Bachelor's Degree in an engineering field and 0 years of experience; or minimum of a Bachelor's Degree in a science-based field and 2 years of relevant experience; or an Associate Degree with a minimum of 5 years of relevant Understanding of quality system requirements including ISO 17025 and 21 CFR part 58 is Must be organized, with excellent analytical and problem-solving abilities and the ability to perform and report basic statistical Ability to read, analyze and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized Has a good understanding of good testing practices and Good verbal and writing skills and good interpersonal and leadership BDC Laboratories is an equal opportunity employer. Job Posted by ApplicantPro
Company:
BDC Laboratories
Posted:
April 15 on ApplicantPro, TalentPlusHire
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More About this Listing: Product Evaluations Engineer I
Product Evaluations Engineer I is a Engineering Engineer Job at BDC Laboratories located in Wheat Ridge CO. Find other listings like Product Evaluations Engineer I by searching Oodle for Engineering Engineer Jobs.
Product Evaluations Engineer I is a Engineering Engineer Job at BDC Laboratories located in Wheat Ridge CO. Find other listings like Product Evaluations Engineer I by searching Oodle for Engineering Engineer Jobs.