Product Evaluations Engineer I

2 days ago

Wheat Ridge, Colorado, United States BDC Laboratories Full time
Job Description

BDC Laboratories 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.

We are 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.

Key Responsibilities:

  • Ensure equipment is adequately calibrated, inspected, cleaned, and maintained prior to use in a laboratory setting.
  • All reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration dates.
  • Support the development of protocols, test methods, and validation.
  • Functions performed are clearly understood and conducted in accordance with the approved procedures.
  • Ensure 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 accurately.
  • All experimental data, including observations of unanticipated responses of the test system, are accurately recorded and documented.
  • All raw data, documentation, protocols, final reports, and specimens (as appropriate) generated as a result of a laboratory study are properly stored and maintained.
  • Perform data analysis and create software scripts and templates to perform data analysis.
  • Unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, and corrective action is taken.
  • Prepare 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.
  • Manage projects in order to keep them on schedule, within scope, within budget, and provide good customer service.
  • Participate in regulatory inspection activities with regulatory agencies, as required.
  • Practice 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 experience.
  • Understanding of quality system requirements including ISO 17025 and 21 CFR part 58.
  • Must be organized, with excellent analytical and problem-solving abilities, and the ability to perform and report basic statistical analysis.
  • 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 members.
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form, and ability to deal with problems involving several concrete variables in standardized situations.
  • Has a good understanding of good testing practices.
  • Good verbal and writing skills, and good interpersonal and leadership skills.

BDC Laboratories is an equal opportunity employer.

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