Process Engineer: Scale-Up & Yield Optimizer (Diagnostics)

Yoh, A Day & Zimmermann Company; Boulder (CO); On-site; USD 9,500 - 105,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Certification and training oportunit­y

Job summary

Yoh Life Sciences in Longmont, CO is seeking a Process Engineer to support transfer and development of new products and processes. You will back manufacturing, maintain and improve equipment, and ensure product quality and yield.

The ideal candidate has a Bachelor's in engineering, 5–7 years in a regulated R&D/production setting, and experience with DOE/ SPC and quality systems. Medical device and cGMP familiarity is a plus.

Qualifications

• 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; 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).

Responsibilities

• Lead sustaining support to operations utilizing continuous improvement principles and technical support.
• Ensure on-time equipment milestone deliveries.
• Recommend and implement equipment and process modifications to improve production efficiencies, manufacturing techniques and yields.
• Assist in developing high level capital equipment integration protocols and procedures for manufacturing.
• Develop and conduct DOE and SPC analyses targeting yield loss and quality; manage data for GR&R, Yield Tracking, and Cpk analysis.
• Document all work products to ensure equipment qualifications per IQ/OQ/PQ.
• Interact with design staff to ensure compatibility of processes and designs with existing equipment.
• Translate design requirements into production by defining and communicating efficient process tooling.
• Utilize GDP to author SOPs and detailed work instructions.
• Train manufacturing staff on proper processes and equipment operation (wave-guide instruments).
• Ensure team follows safety rules and protocol.

Skills

Problem solving

Communication skills

Data analysis

Team collaboration

DOE/ SPC knowledge

Education

Bachelor's degree in engineering or related field

Master's degree preferred

Certifications such as ISO, PMP, Lean, Six Sigma

Tools

SolidWorks

MS Office

Windows OS

Job description

Yoh Life Sciences in Longmont, CO is seeking a Process Engineer to support transfer and development of new products and processes. You will back manufacturing, maintain and improve equipment, and ensure product quality and yield.

The ideal candidate has a Bachelor's in engineering, 5–7 years in a regulated R&D/production setting, and experience with DOE/ SPC and quality systems. Medical device and cGMP familiarity is a plus.