Senior Materials Engineer

LifeLens Technologies, LLC.; Northern (KY); Hybrid; USD 120,000 - 160,000; 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 Materials Engineer to lead materials development for SAC technology and scale-up processes.

You will formulate and qualify materials, drive FDA-compliant in-house manufacturing plans, and partner with suppliers to ensure GMP, quality, and device safety.

The role requires 5+ years in healthcare materials, advanced degree, and strong analytical skills; on-site work with competitive benefits.

Qualifications

• Experience in polymer chemistry, soft materials development and characterization.
• Healthcare/medical devices material development experience preferred.
• 5+ years in material development for healthcare manufacturing.
• Familiar with FDA, QSR, cGMP, ISO13485 and EU rules.
• Strong communication and problem-solving skills.

Responsibilities

• Strategic direction for formulation and material development for scale-up.
• Prototype formulations meeting mechanical, electrical, and physical properties.
• Observe processes, collect data, and implement throughput/quality improvements.
• Define engineering specifications and process documentation.
• Lead Materials and Processes technical assignments.
• Troubleshoot problems and develop innovative solutions.
• Lead supplier qualification, testing, and failure analysis.
• Develop FDA-compliant in-house manufacturing plans; qualify contract manufacturers.
• Ensure production meets GMP requirements and supports business targets.
• Drive continuous improvement for scalable operations.
• Evaluate cGMP compliance using KPIs.
• Work in a collaborative, cross-functional team.
• Other tasks as assigned.

Skills

Polymer chemistry

Soft materials development

Composite development

Material development

Quality engineering concepts

FDA/QSR/cGMP knowledge

ISO13485 knowledge

Product qualification testing

Microsoft Office

Communication skills

Education

Master’s degree in Polymer Science, Chemistry or related field

Tools

Microsoft Office

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 Materials 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 materials engineer is responsible for managing the development and application of various materials and formulations in the development of the Company’s SAC technology. They will research available materials, characterize material/formulation properties and evaluate impact to the overall product design. In addition to material development and evaluation, the senior materials engineer will develop formulations and processes to support manufacturing scale-up and process validation.

Essential Functions

• Provide strategic direction in formulation and material development for manufacturing scale-up.
• Prototype formulations to meet mechanical, electrical, and physical properties
• Observe manufacturing processes, collect, correlate data and implement process improvements to focus on throughput and quality.
• Define and document engineering specifications and process documentation used in the manufacturing process.
• Lead Materials and Processes technical engineering assignments
• Troubleshoot problems and find innovative solutions
• Lead the selection, qualification, testing, and failure analysis of materials & processes, prepare technical and progress reports on assigned tasks, prepare specifications, evaluate suppliers and analyze test reports
• Develop and drive FDA-compliant in-house manufacturing plans and identify suitable contract manufacturers for high volume.
• Ensure production is in line with GMP requirements and actively provide tactical direction to support the business targets.
• Drive continuous improvement to enable the organization to scale efficiently and effectively.
• Evaluate the level of cGMP compliance for products manufactured, packaged, tested and released through Key Performance Indicators (KPIs).
• Work in a collaborative and cross functional team
• Other tasks as assigned
  

Competencies

• Experience in polymer chemistry, soft materials development and characterization required.
• Experience with composite development and associated manufacturing processes required.
• 5+ years’ experience preferred in material development for manufacturing in healthcare and/or medical devices.
• 5+ years’ experience in material development applications preferably in healthcare and/or medical devices.
• Experience with quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.
• Familiarity with FDA, QSR, cGMP, ISO13485, and EU rules and regulations.
• Working knowledge of product qualification testing, inspection tools and equipment, and supplier quality activities
• Knowledge of materials, finishes, and specifications (SAE, ASME, ANSI, etc.)
• Excellent quantitative and analytical skills.
• Ability to prioritize tasks in a fast-paced environment.
• Must be functional with Microsoft Office, including Word, Power Point, and Excel
• Strong interpersonal and communication skills

Required Education

• Master’s degree or PhD. in Polymer Science, Chemistry or a related technical discipline preferred

Benefits

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