SENIOR MATERIALS ENGINEER
Posted December 9, 2020
LifeLens Technologies, LLC. is a medical device developer located in Warminster, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.
You will have the opportunity to work on cutting-edge technologies designed to revolutionize wearable health care. Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.
The ideal candidate is a capable team leader who enjoys working in a start-up environment. You are detailed oriented and goal driven. You are a capable problem solver who is comfortable researching solutions autonomously. You have excellent organizational skills and superior verbal and written communication skills.
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 throughout 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
Experience in polymer chemistry, soft materials development and characterization required.
Experience with composite development and associated manufacturing processes required.
10+ years’ experience preferred in material development for manufacturing in healthcare and/or medical devices.
10+ 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 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
Master’s degree or PhD. in Polymer Science, Chemistry or a related technical discipline preferred
To apply, send a pdf of your resume to firstname.lastname@example.org. Please write Materials Engineer in the subject line