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.
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 25 lbs. and occasionally lift and carry up to 50 lbs.
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.
Job Type: Full-time
Pay: From $30.00 per hour
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Paid time off
Referral program
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Overtime
Education:
Bachelor's (Preferred)
Experience:
Manufacturing: 1 year (Preferred)
Medical Device: 1 year (Preferred)
Work Remotely:
Yes, occasionally