Injection Molding Engineer

Henry Spencer

**** ****** ****** ********* #*** Saint Paul, Minnesota – 55116 – 612-***-**** – *************@*******.*** – https://www.linkedin.com/in/henryspencer1

US CITIZEN

Education

• University of Minnesota – Twin Cities – Master of Science Mechanical Engineering – May 2018

• University of New South Wales – Australia – Master of Biomedical Engineering – 2017

• University of Technology, Sydney, Australia – Master of Pharmaceutical Sciences – 2014

• Florida Atlantic University, West Palm Beach, Florida – Bachelor of Science Chemistry: Biochemistry – 2011

• University of Stockholm, Stockholm, Sweden – Bachelor of Science, International Economics – 1999 Skills

• Proficient in Microsoft Word, PowerPoint, Excel, Access, TrackWise and Oracle, Minitab

• Understanding of 21 CFR 820.30 and ISO 13845 requirements

• Understanding of FDA Quality System Regulation

• Familiarity with 8 Disciplines Problem Solving methodologies

• Strong technical writing and critical thinking

• Process and detail oriented

• Speaks Swedish and English

• Vacuum & pressure forming, Spray Forming;

• Punching & Blanking; Geometric Design & Tolerancing,

• Technical Writing, AutoCAD

Work Experience

BCS TECHNOLOGY Sydney, New South Wales May 2012 – May 2017 Manufacturing Engineer

Responsibilities

• Ensuring that Injection Molding and Extrusion Molding machines operated according to required standards and product specified ranges

• Troubleshooting and resolving problems on Extrusion and Injection Molding machines like: High motor amperage, Interrupted resin output, Uneven flow, Unmelted particles, Sharkskin, Discolored extrudates, etc.,

• Developing process validation protocols, Conducted and taught Operational Qualification processes, Conducted Performance Qualification assessments, and Installation Qualifications and Validation of new equipment, including challenges under loading, CAPA, Design for Manufacturing

• Conducting Gemba walks and interfacing with other engineering departments, customers, and suppliers on quality related issues

• Completing complaint investigations in a uniform and timely manner for neurovascular medical devices in accordance to 21 CFR Part 803 Medical Device Reporting

• This includes complex returned product investigation, device history report review, labeling review, risk assessment, root cause analysis, etc

• Handling complex investigation data analysis and consulting with R&D, sustaining and quality engineers to appropriately assign probable causes

• Presenting monthly Complaint Review Board (CRB) meeting to management, looking at complaint trending

• Investigating trends and escalating to non-conformance if necessary

• Assisting with product training for new Quality team members as needed

• Involved in internal/external audit preparation and support all external/internal audits as required

• Responsible for receiving all complaint products and tracking receipts and shipments in complaint handling system

• Closing Return Material Authorizations (RMAs) in Oracle database for returns

• Conducting periodic inspection visits to suppliers in Malaysia, Singapore, Cambodia and Vietnam as required under Australian ISO 9001 regime

Roseville and Bloom Pharmacies – Gordon, New South Wales Jan 2013 – Nov 2014 Intern Pharmacist

Responsibilities

• Provided pharmaceutical services at two different locations in the region

• Review clinical study data packets and logbooks for good documentation practices and compliance to GLP and GDP standards

• Prepare clinical study binders and Maintaining fire filing system for the Clinical Testing Group

• Update and Revise Standard Operating Procedures and Generated Deviation Reports and Note to Files

• Patient Care: Significantly increased the rate of patient compliance with the taking of blood pressure medications through effective communication: Efforts directly led to an increase in sales (blood pressure medications and home blood pressure measuring devices) resulting in increased sales

• Devised innovative method to ensure correct dose of medication was dispensed, thereby reducing erroneous dispensing

TECHNICAL PROFICIENCIES

Biomechanical

Engineering:

Mechanics of the Human Body; Gait Analysis; Design of Modern Prosthetics; Custom Prosthetics; Biological Signal Analysis; Design of RC Circuits; Troubleshooting Diagnostic Devices; Matlab programming; Design of Experiments; Analog and Digital Signal Processing; Biomedical Instrumentation; Dialyzer Design and Performance; Clearance and Flow rates; Hemofiltration; Peritoneal Mass Transfer; Transdermal Delivery Designs

Biocompatibility and

Medical Devices

Regulations:

Quality Control, Product Validations, System Validations, Polymers, Metals & Ceramics; Biocompatibility Testing Guidelines – ISO 10993; Regulatory pathways to registering medical devices in the United States, Australia and New Zealand, the European Union, China, Japan. ISO 9000/ISO 13485 Harmonization; GLP, GCP, GMP, QSR and Validation; Class I, Class II and Class III devices approval process in the US, Australia, Europe, China & Japan; Chemistry, Manufacturing & Control Protocols – CMCs, Investigational Device Exemptions – IDEs, Pre-Market Applications, Pre-Market Notifications – 510(K)s and general CTD Pyramid

Additional Experience

Possess additional experience in the compounding and administration of Galenicals, Adverse Drug Reactions monitoring and Reporting, Pharmaceutics, Biopharmaceutics, Monoexponential and Multiexponential Pharmacokinetics, Bioequivalance and Intravenous Infusions and Renal Functions monitoring, Good Laboratory Practices and Good Manufacturing Practices.

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