Current Job Openings

Analyze, design, build, test, and troubleshoot various types of medical equipment and analytical lab instruments for our clients in the life-sciences industry. Apply thorough knowledge of validating software and database systems for medical and healthcare purposes - requirements gathering, risk analysis, test-protocol generation (IQ, OQ, PQ), trace matrices, and summary reports - including cGMP and quality-system regulations. Utilize FDA compliance regulations with cGxP standards, including 21 CFR Part 11/210/211/820 and OSHA.

Qualifications: Master's degree in Chemical Engineering or related fields.

Gather, analyze, and validate data to evaluate and design systems and procedures that improve workflow and quality assurance, helping management operate more efficiently. Review and evaluate healthcare projects and provide input for continued improvement. Gather requirements and generate reports in adherence to Information Asset Protection, Sarbanes-Oxley, and GxP policies. Perform gap analysis and propose new specifications to resolve change requests. Prepare and update monthly reports/metrics and highlight significant changes in management metrics, KPIs, and performance statistics.

Qualifications: Master's degree in IT/Management or related fields.

Analyze, design, build, test, and troubleshoot various types of electronic and other medical equipment/instruments. Validate analytical laboratory equipment, software, and database systems used for medical and healthcare purposes. Ensure system compliance with cGxP standards such as 21 CFR Part 11/210/211/820, OSHA, and FDA regulatory guidelines. Develop and maintain lab automation and equipment validation, collaborative technologies, and distributed control of applications in accordance with GMP and FDA regulations. Travel/relocate to various unanticipated locations to interact with clients and train users for short- and long-term projects.

Qualifications: Master's degree in Biomedical Engineering or related fields.

Prepare, process, analyze, compile, and submit global regulatory submissions such as 510(k), PMA, European dossiers, and Japanese STED accurately per FDA and international regulations for new and modified medical devices. Must know current/proposed regulations, facility registration, device listing, testing standards, labels, and import/export requirements used in medical devices. Experience with Matrix, Agile, and Trackwise document-management tools. Travel/relocate to various unanticipated locations to interact with clients and train users for short- and long-term projects.

Qualifications: Master's degree in Regulatory Affairs, Pharmacy, or related fields.