Validation Engineer - Direct Hire - Medical Manufacturing
This Jobot Job is hosted by: Katherine Opie Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $80,000 - $90,000 per year
A bit about us:
Based in Mooresville, Indiana - we are a leading supplier of foam and plastic products with manufacturing locations nationwide and in Mexico. This is a newly created position at our growing mid-sized medical equipment manufacturing site. This role requires cross-functional coordination within our company and offers substantial visibility as well as growth. If you are a Validation Engineer interested in working for a company with a great culture to design, build and manufacture cutting-edge medical devices, please read on!
Why join us?
Competitive Benefits & Compensation Package • Paid Time Off (PTO) • World-class benefits • Team environment with positive culture • Safe working environment including climate-controlled production and a clean manufacturing environment • Company paid short-term disability, long-term disability, and AD&D insurance • 401k with employer match • Tuition reimbursement program • Dependent education program • Wellness program • Paid training • Career development opportunities • Referral bonus for all full-time referrals • Competitive wages • Annual opportunities for increases and bonuses
Job Details
The Validation Engineer is responsible for the development and qualification of reliable and robust manufacturing processes.
This position will serve as the subject matter expert (SME) on process qualification and validation for manufacturing processes such as:
raw material and film converting
die cutting, radio frequency (RF) welding
UV gluing and solvent bonding, sewing
assembly for new product introduction and legacy products
ESSENTIAL FUNCTIONS: • Lead a cross-functional team in process qualification and validation efforts, including development and maintenance of a site Master Validation Plan (MVP) and individual project validation plans. • Author and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. • Create and maintain essential process documentation, including process flow diagrams, risk analyses such as Potential Failure Mode and Effects Analysis (PFMEA) and risk matrices. • Evaluate and qualify test and inspection methods, including tensile testing, dimensional inspection, and in-line inspection through use of measurement studies and Test Method Validation (TMV). • Perform studies to evaluate and optimize processes using DOE, screening experiments, response surface methodology (RSM), or other techniques. • Evaluate existing processes for improvement opportunities, generate documentation necessary to support and justify recommendations, and implement improvements. • Write SOPs for equipment operation, and product inspection. • Serve as the facilitator for engineering change control (ECR/ECN) meetings. • Support CAPA activity, including failure investigation, root cause analysis, and implementation of corrective action.
EDUCATION/EXPERIENCE:
Bachelor's degree in engineering, such as mechanical, industrial, or biomedical, is strongly preferred.
Must have comprehensive computer proficiency, including MS Office suite and ERP/MRP software.
Five or more years of experience in a regulated manufacturing environment.
DESIRED SKILLS FOR THE JOB:
Prior experience with plastics joining processes, particularly RF welding, is a bonus.
Knowledge and experience with medical device manufacturing.
Familiarity with ISO 13485 and current Good Manufacturing Processes (cGMP) as defined in 21 CFR Part 820.
Knowledge of statistical tools and techniques for manufacturing and validation, such as measurement system analysis (MSA), design of experiments (DOE), statistical process control (SPC), sample size determination, and confidence and reliability calculations.
Certification or prior experience with continuous improvement such as Lean Six Sigma is highly desirable.
Experience with AutoCAD and/or Inventor is a plus.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
