Lateral Flow Specialist

Yoh; Boulder (CO); On-site; USD 74,000 - 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

Job summary

Yoh Life Sciences is hiring for a Process Engineer II in Longmont, CO. You will support transfer and development of new products and processes, maintaining equipment and ensuring product quality and yield.

The role emphasizes continuous improvement, DOE, and SPC in a regulated setting.

Qualifications

• Bachelor’s degree in engineering or related field required; master’s degree preferred.
• 5–7 years in R&D or production with process improvement/scale-up experience.
• Experience in regulated environments (FDA/ISO) preferred.
• Experience in project management preferred.
• Experience in the medical device field, specifically in vitro diagnostics, preferred.
• ISO/PMP/LEAN/MPS Six Sigma or cGMP certifications preferred.
• Excellent written and verbal communication skills; able to relay technical information clearly.

Responsibilities

• Lead sustaining support to operations using continuous improvement principles and root-cause analysis for corrective actions.
• Ensure on-time equipment milestone deliveries to enable company growth.
• Recommend and implement equipment and process changes to improve production efficiency and yields.
• Develop high-level capital equipment integration protocols for manufacturing.
• Perform DOE and SPC with GR&R, and Cpk analyses to improve yield and quality.
• Document work products to comply with IQ/OQ/PQ requirements.
• Collaborate with design staff to ensure processes align with equipment capabilities.
• Translate design requirements into efficient production tooling and GDP-compliant documents.
• Train staff on proper processes and equipment operation.
• Enforce safety rules and protocols.

Skills

Continuous improvement

Root cause analysis

DOE

SPC

GR&R

Cpk analysis

Documentation IQ/OQ/PQ

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

Windows

MS Office

SolidWorks

Job description

Yoh Life Sciences is hiring for a Lateral Flow Specialistin Longmont, CO for a leadingdiagnostic company. The Process Engineer will support transfer and development of new products and processes. You will supportmanufacturing, whilemaintaining and improving upon existing equipment as well as ensuring product quality and yield.

Position: Process Engineer II

Pay: $84,000-105,000 DOE

Location: Longmont, CO

Duration: FTE

• We are looking for either somebody with microarray printing experience, preferably with Biodot equipment.
• Looking also for lateral flow test manufacturing experience, preferably with reel-to-reel spraying development experience.

Responsibilities

• 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.

Experience

• 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).

Estimated Min Rate: $73500.00

Estimated Max Rate: $105000.00

What's In It for You?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.