Product Development Engineering Technician

Job Description

The primary focus of this position is to assist R&D engineers in medical device process development and testing. This includes developing, optimizing, building units for engineering, performing tests, and collecting and analyzing data. Candidate will support EU MDR efforts.

Essential / Key Job Responsibilities

• Product Builds: Assist, coordinate and build product part or prototype builds for engineering evaluation and validation.
• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests, and test protocols that comply with GMP and Quality requirements.
• Test Method Development: Review test methods during test method development and assist with test method validations. Assist in creating or writing test methods as needed and assist in generating and designing basic testing fixtures.
• Testing: Ability to set up testing by preparing equipment and records. Ability to perform tests by following instructions from development engineers; collect data and record test results; analyze test data, organize and present when necessary in a reportable format.
• Training: Provide 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. Ensure equipment is operating properly. Obtain quotes for testing and calibration.
• Materials/Inventory: Generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices.
• Other Responsibilities: Assist in the support of Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

Required Qualifications

• Minimum of a Highschool Diploma/GED. Associates of Science degree in a technical discipline preferred.
• Experience: 0-3 years of industrial experience in R&D or process development preferably in medical device or other regulated FDA/QSR and ISO environment.
• Ability to work in a team.
• Ability to follow/integrate instructions (written/verbal), collect data and record results.
• Task oriented.
• Excellent communications skills (written/verbal).
• Technical writing proficiency.
• Experience working in a laboratory and a controlled environment (cleanroom) is a plus.
• General aptitude with testing and manufacturing equipment.
• Basic troubleshooting skills, exposure to product failure, and root cause investigations.
• Ability to assist in executing and/or writing validations.
• Ability to operate lab equipment.
• Basic computer skills (MS Windows, MS Outlook, Word, Excel, and PowerPoint).
• Basic math/statistics skills.
• Basic knowledge of GR&R.
• Basic knowledge of standard laboratory practices.
• Works well under limited supervision.

Physical Demands

• This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions.
• The incumbent may also be required to lift up to twenty-five pounds occasionally.
• The incumbent may be required to stand for extended periods of time.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment.
• Bending, stooping, and reaching are also frequently required.
• The employee is also frequently required to verbally communicate with other associates.
• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

• While performing the duties of this job, the employee may be in an open cubicle environment.
• Candidate must be able to work in a team-oriented, fast-paced environment.