Senior Process Development Engineer

LifeLens Technologies Inc.; 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. in Ivyland, PA, seeks a Senior Process Development Engineer to lead validation, risk analysis, and process optimization for wearable medical devices.

You will guide engineers, improve production lines, and drive development from research to production while ensuring design for manufacturability. The role requires hands-on leadership, experience with ISO9001/13485, and strong problem-solving; on-site work with a team focused on innovative health monitoring devices.

Qualifications

• Advanced degree in Polymer Science, Chemistry, Chemical Engineering or a related technical discipline is preferred.
• Medical device manufacturing experience is required.

Responsibilities

• Lead process validation activities including IQ/OQ/PQ protocols and reports, with acceptance criteria.
• Lead and document process risk analyses with statistical sampling plans.
• Establish stable, capable processes meeting manufacturing and quality goals.
• Implement process development discipline and best practices.
• Explore and develop novel processes as designs evolve.
• Support daily manufacturing through process engineering and continuous improvement.
• Evaluate process changes and material interactions.
• Conduct process DOE studies and document reports.
• Implement safety protocols for manufacturing equipment.
• Collaborate with Quality and R&D in process development.
• Other tasks as assigned

Skills

Process development

DOE

Statistical analysis

IQ/OQ/PQ validation

Polymer materials

Leadership

Manufacturing experience

Microsoft Office

ISO9001/ISO13485

Education

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

Tools

Minitab

Excel

PowerPoint

Word

Job description

LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.

We are seeking to hire a Senior Process Development Engineer. In this role, you will have the opportunity to work on cutting-edge technologies designed to revolutionize wearable health care. You have a collaborative mindset and a passion for developing new technology. Youare detail-oriented and goal-driven. You are a capable problem solver with excellent organizational skills and superior verbal and written communication skills.

Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.

This is a full-time, on-site position.

Summary

The Senior Process Development Engineer is responsible for developing and validating processes to manufacture LifeLens products. This role participates in all phases of product development including research, design, and production. They will work with a team of engineers to ensure the smooth functioning of production lines; to develop new techniques; to modify existing designs; and to coordinate process improvement projects. They will have the technical knowledge and leadership skills to play a vital role in developing products that meet our customer’s needs.

Essential Functions

• Lead process validation activities including authorship and completion of installation, operational, and performance qualification (IQ/OQ/PQ) protocols and reports. Evaluate process requirements and determine appropriate validation acceptance criteria.
• Lead and document process risk analysis activities including implementation of statistical sampling plans and testing strategies to ensure process outputs meet product specifications.
• Establish stable and capable processes meeting company manufacturing and quality goals.
• Implement process development discipline and best practices.
• Explore and develop novel processes as designs evolve.
• Support daily manufacturing activities through process engineering development and continuous improvement projects.
• Evaluate process changes and material/composition interactions.
• Conduct process trials with appropriate protocols and documentation.
• Implement safety protocols for manufacturing equipment.
• Work with Quality and R&D in process development.
• Conduct process DOEs and author process reports for studies
• Other tasks as assigned

Competencies

• Worked under ISO9001 and/or ISO13485 manufacturing standards.
• Medical device manufacturing experience required.
• Experience leading a team of engineers and technicians in a manufacturing environment.
• Solid understanding of roll-to-roll manufacturing processes.
• Process validation/verification and FMEA.
• Experience with DOE, conducting experiments, and analyzing results using statistical analysis software.
• Must be knowledgeable of polymer materials
• Must be a versatile, self-starter who can manage several different aspects of the given project
• Must be detail oriented
• Must be functional with Microsoft Office, including Word, Power Point, and Excel

Required Experience and Education

• Advanced degree in Polymer Science, Chemistry, Chemical Engineering or a related technical discipline preferred

Benefits

• Health Insurance
• Dental & Vision Insurance
• Paid Time Off
• 401(k)
• Stock option incentive plan
• FSA & dependent care