Process Engineer II Job at Antech Diagnostics (Longmont)

Job Description

A Process Engineer II is required to maintain day-to-day operations in manufacturing, maintaining and improving upon existing equipment as well as ensuring product quality and yield. A Process Engineer II works closely with other teams and under the guidance of their manager to transfer and develop new products and processes. A Process Engineer II understands appropriate documentation in a regulated environment, implementing corrective actions, and experience with continuous improvement principles.

Job Responsibility

Lead efforts to provide sustaining support to operations utilizing continuous improvement principles and technical support to operations utilizing root cause analysis to implement corrective actions
Enables company growth by ensuring on-time equipment milestone deliveries
Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products
Assists in developing high level capital equipment integration protocols and procedures for manufacturing
Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC)
Accurately documents all work products to ensure equipment qualifications
Interacts with design staff to ensure that processes and designs are compatible with existing equipment
Translate design requirements into production
Utilizing GDP, author documents including but not limited to manufacturing Standard Operating Procedures (SOPs), and detailed work instructions
Trains manufacturing staff on proper processes to follow when operating equipment
Ensures that team and staff members follow safety rules and protocol
Other duties as assigned

Requirements

Bachelor’s degree in engineering or related field required
master’s degree preferred
Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement and scale-up projects
Experience in a regulated environment (FDA, ISO, etc.), preferred
Experience in project management preferred
Experience in the medical device field, specifically invitro diagnostics, preferred
Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP, preferred
Excellent written and verbal communication skills
Excellent problem-solving skills
Excellent data gathering and analysis skills
Excellent electro-mechanical equipment development and troubleshooting skills
Knowledge of QMS
Software use and knowledge: Windows, MS Office products, SolidWorks (or similar)
Able to develop effective partnerships across the organization
Self-starter
Highly organized and able to balance multiple demands

Nice to have

Experience in a regulated environment (FDA, ISO, etc.)
Experience in project management
Experience in the medical device field, specifically invitro diagnostics
Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

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Process Engineer II

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