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The Target Pay Range for this position is $84,000 - $105,000 annually. At Antech, pay decisions are determined using factors such as relevant job-related skills, experience, education, training and budget.

Job Purpose/Overview

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.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to satisfactorily perform each essential function. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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) targeting physical cause of failure for yield loss and improving quality. Active database and data management allowing for process performance assessment via GR&R, Yield Tracking and Cpk analysis.

• Accurately documents all work products to ensure equipment qualifications and in line with and follow IQ, OQ, PQ requirements.

• Interacts with design staff to ensure that processes and designs are compatible with existing equipment.

• Translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling.

• 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, including wave-guide instrument(s).

• Ensures that team and staff members follow safety rules and protocol.

• Other duties as assigned.

Education and Experience

• Bachelor6s degree in engineering or related field required; master6s 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.

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills; able to communicate technical information to technical and non-technical staff to ensure understanding.

• Excellent problem-solving skills and demonstrated ability to collaborate in problem solving.

• Excellent data gathering and analysis skills.

• Excellent electro-mechanical equipment development and troubleshooting skills.

• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.

• Software use and knowledge: Windows, MS Office products, SolidWorks (or similar).

• Able to develop effective partnerships across the organization and to serve as a liaison between R&D and Manufacturing.

• Self-starter, with ability to work on own initiative.

• Highly organized and able to balance multiple demands and priorities.

Travel

Will there be notable travel in this position? Yes

Percent of time: 10%

Working Conditions

Complete how the job gets done and the way it operates

The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak in order to use the telephone, make presentations and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 25 pounds.

Work will be performed in an office, laboratory, and assembly/manufacturing environment. Able to use standard office equipment, know and understand laboratory safety protocols, and operate in an around process assembly equipment. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.

Benefits

Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.

Benefits eligiblity is based on employment status.

• 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