Patrick Caren
Summary
Hardworking and passionate job seeker with strong organizational skills eager to secure a position in the Biomedical Engineering field as a Validation/Quality Engineer or equivalent. A quick learner who is ready use my lateral thinking skills to help team achieve company goals.
Overview
7
7
years of professional experience
Work History
Validation Engineer/Quality Engineer
Cook Medical Via Akkodis
05.2022 - 02.2023
- Documented entire validation process, noting changes or alterations completed.
- Compiled Inspection Assessment Plans for Quality Control to evaluate methods and language of training documents according to company and FDA standards.
- Drafted Master Validation Plans (MVPs) and Test Method Instructions (TMIs).
- Responsible for tracking and reporting field/customer complaints and returns, possibly leading/assisting in moderate CAPA investigations, risk reviews, and product improvement projects.
- Used hand-held and microscope cameras to capture images for Test Method Instructions.
- Worked with Subject Matter Experts (SMEs) during the design of test plans and the updating of business requirements.
- Involved in Equipment qualification/validation and product/process validation Quality System Regulations(QSR) deliverables including Installation Qualification (IQ), Operational Qualification (OQ),Product/Process Qualification (PQ), Test Method Validation (TMV), Failure Mode Effects Analysis (FMEA).
- Conducted inter-disciplinary meetings to further understanding of medical devices and confirm legibility of documentation.
Senior Segmentation Representative
Stryker Via Actalent
02.2022 - 03.2022
- Reviewed and Segmented CT scans with proprietary software to create 3D anatomical bone models.
- Created pre-operative surgical plans and landmarks for robotically assisted Total Hip and Total Knee Arthroplasty.
- Documented all activities in detail according to procedure.
Shadowing Student
Wright & Filippis
09.2021 - 01.2022
- Observed central fabrication process for custom-made prosthetics.
- Followed industry professionals to learn appropriate methods for solving issues and best practices for task completion.
- Attended appointments for consultation, measurement, and adjustment for orthopedic and prosthetic devices.
Pharmacy Technician
Rite Aid
04.2021 - 10.2021
- Calculated dosage, prepared prescriptions, and prepared prescription labels following standard procedure.
- Maintained continuous perpetual inventory of hundreds of medications.
- Prepared and processed documentation for medications and consent forms for certain procedures such as vaccinations.
- Protected patients and their information via procedures for organizing and securing electronic and physical data.
Drug Testing Technician
Bay Tech Staffing
02.2018 - 08.2020
- Managed clients based on procedures, results, and client behavior.
- Prepared test samples and recorded test data in accordance with standards for each sample and reported findings to Oakland County Probation Agents.
- Adhered to the security and confidentiality standards of the laboratory.
Research Assistant
Lawrence Technological University
05.2016 - 05.2017
- Simulated medical devices via Abaqus Computer Aided Engineering.
- Produced 3D objects based on 3D object scans or medical imaging scans such as Computed Tomography for simulations or use in other programs.
- Prepared samples for dental device testing, development, and training.
Education
Bachelor of Science in Biomedical Engineering -
Lawrence Technological University
05.2017
Skills
- CAD
- AutoCAD
- MATLAB
- Laboratory Experience
- Calibration
- Research & Development
- SolidWorks
- Mechanical Engineering
- Drafting
- Product Development
- Mechanical Knowledge
- Anatomy knowledge
- Medical terminology
- Physiology knowledge
- Agile
- Process Analysis
- Effective Communication
- Math Skills
- Regulatory Guidelines
- Testing Protocols
- Process Validation
- Critical Thinking
- Validation Standards
- Regulatory Compliance
Personal Information
Relocation: Anywhere
Timeline
Validation Engineer/Quality Engineer
Cook Medical Via Akkodis
05.2022 - 02.2023
Senior Segmentation Representative
Stryker Via Actalent
02.2022 - 03.2022
Shadowing Student
Wright & Filippis
09.2021 - 01.2022
Pharmacy Technician
Rite Aid
04.2021 - 10.2021
Drug Testing Technician
Bay Tech Staffing
02.2018 - 08.2020
Research Assistant
Lawrence Technological University
05.2016 - 05.2017
Bachelor of Science in Biomedical Engineering -
Lawrence Technological University
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