Senior Process Development Engineer, Medical Devices

LifeLens Technologies, LLC.; Ivyland (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental & Vision Insurance

Paid Time Off

401(k)

Stock option incentive plan

FSA & dependent care

Job summary

LifeLens Technologies, Inc. is seeking a Senior Process Development Engineer to develop and validate manufacturing processes for LifeLens products.

You will work with a team of engineers to ensure smooth production, develop new techniques, modify designs, and coordinate process improvement projects that meet customer needs. The role requires leadership in process validation, risk analysis, DOE, and collaboration with Quality and R&D, all within ISO9001/13485 manufacturing environments.

Qualifications

• Advanced degree in a technical discipline is preferred.
• Experience in medical device manufacturing and ISO standards is required.
• Ability to lead a team of engineers and technicians in manufacturing.

Responsibilities

• Lead process validation activities including IQ/OQ/PQ protocols and reports.
• Conduct process risk analysis and develop testing strategies to ensure specifications.
• Establish stable, capable processes meeting quality goals.
• Implement process development discipline and best practices.
• Develop novel processes as designs evolve.
• Support daily manufacturing through development and continuous improvement.
• Collaborate with Quality and R&D on process development.
• Perform DOEs and document process studies.
• Implement safety protocols for manufacturing equipment.

Skills

Process validation

IQ/OQ/PQ

Statistical analysis

DOE

FMEA

Roll-to-roll

Polymer materials

Leadership

Microsoft Office

Education

Advanced degree in Polymer Science, Chemistry, Chemical Engineering or related

Tools

Minitab

Job description

LifeLens Technologies, Inc. is seeking a Senior Process Development Engineer to develop and validate manufacturing processes for LifeLens products.

You will work with a team of engineers to ensure smooth production, develop new techniques, modify designs, and coordinate process improvement projects that meet customer needs. The role requires leadership in process validation, risk analysis, DOE, and collaboration with Quality and R&D, all within ISO9001/13485 manufacturing environments.