Description

Job Summary:

The Manufacturing Engineer I supports the medical device manufacturing process.

Essential Job Duties and Responsibilities:

• Develops, documents and optimizes manufacturing processes and operating procedures within a regulated quality system utilizing lean manufacturing principles.
• Ensures all projects/processes are in compliance with FDA, Current Good Manufacturing Practices (cGMP), Quality System Requirement (QSR), ISO-13485 and other applicable requirements.
• Writes, reviews, and approves validations (IQ/OQ/PQ protocols), Standard Operating Procedures (SOP), technical reports and final reports for new products, processes, and equipment.
• Constructs and executes controlled experiments (including DOE's) to troubleshoot production line issues, address yield and quality issues and drive implementation of solutions to meet production goals.
• Assists in identification and implementation of advanced manufacturing technologies and makes recommendations for process requirements of new or existing product lines
• Assists in the review and evaluation of capacity models and anticipates when new equipment or additional headcount will be required.
• Evaluates technical problems and drives down to root causes in order to implement sustainable resolutions.
• Trains manufacturing personnel.

Qualifications

Education, Experience, Skills, & Abilities:

• BS Degree in Engineering with specific experience in working in a medical device and/or biopharma manufacturing environment
• Minimum 1 year of experience in an engineering function dealing with processes and equipment in a cGMP/FDA/ISO manufacturing environment.
• Proven experience including process documentation, IQ/OQ/PQ protocols, and reporting.
• Experience with batch mixing, bottle filling, and packaging equipment a plus
• Previous experience in the areas of SPC, Design of Experiments DOE, and product/process Failure Mode and Effects Analysis FMEA.
• A proven self-starter with the ability to identify areas of improvement and/or need and act accordingly to produce objective results.
• Excellent communication, organizational, and time management skills; ability to pay close attention to detail. Ability to work as part of a team and drive completion of action items.
• Flexibility to change direction frequently and with little notice.
• Ability to manage multiple priorities and tasks and projects.
• Strong problem-solving and analytical skills.

Physical Requirements:

• Ability to sit, use hands and fingers, talk or hear, and smell continually. Ability to stand, walk and reach frequently. Ability to climb or balance, stoop, kneel, or crouch occasionally.
• Ability to frequently lift and carry up to 10 lbs. and occasionally lift and carry up to 25 lbs.
• Close vision required to use a microscope, read documents, and operate the machine. Distance vision required to drive an automobile, if driving is a requirement of the job.
• Work environment is indoors and climate-controlled. Occasionally exposed to outdoor weather conditions.
• Moderate noise levels as found in a light industrial environment, office environment, households with TVs and dishwashers, and driving light traffic.