Product Development Engineering Technician - Mid Level

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Product builds: Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales.
• Sets up and operates manufacturing equipment.
• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development.
• Affords conceptual input to the design of fixtures, tooling and equipment, as well as assists with recommendation, specification and procurement of capital equipment.
• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.
• Test Method Development: Review test methods during test method development and assists with test method validations.
• Testing: Ability to perform tests by following instructions from development engineers; collect data and record test results; analyzing test data, organizing, and presenting to peers and management when it is necessary in a reportable format.
• Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.
• Covers testing of released protocols.
• Training: Provides process/test method training to manufacturing and QA personnel.
• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule.
• Ensures equipment is operating properly. Obtains quotes for testing and calibration.
• Materials/Inventory: generates purchase orders, coordinates orders and deliveries with vendors, R&D stock checking including monitoring material and test inventory, shipping materials/receiving materials including to/from sterilization, ship testing and conditioning for R&D products, prepares commercial invoices and liaises with internal Customs specialists.
• Supervisory/mentoring/coaching: peer-peer coaching other technicians on R&D based tasks and responsibilities.
• Oversees activities of junior technicians in conjunction with their Engineering supervisor.
• Fiscal: reviews inventory reports, the transfer of R&D items to financial logs and relays information to R&D engineers/Project Leaders/R&D Managers for discussion with Finance.

Other Responsibilities

May include, however are not limited to:

• Supports Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Supports design and process root cause analysis and supports non-conforming product and complaint investigations.

Required Qualifications

• N/A

Preferred Qualifications

• Associates degree or higher in science, math or engineering preferred.

Education and/or Experience

• Education: ? ISCED Level 3, insert local education e.g. High school diploma, GCSE, Secondary Education/School, Leaving Certificate? or equivalent experience.
• Experience: Minimum 8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment.
• Ability to work without supervision.
• Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is a plus.
• Experience in process validation (IQ, OQ and PQ); ability to assist in executing validation.
• Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.
• Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis.
• Exposure to statistical analysis and experimental design helpful.
• Ability to design (fixture, equipment, and testing).
• Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).
• Interpret and understand geometric tolerances.
• Experience of electronic tools and equipment (soldering, multi-meter, oscilloscope and analyzer, etc.) is preferred.