Senior Materials Engineer
Benefits are 100% paid by the company for the entire family.
This is an on-site, full-time position that starts immediately. Might be able to work one day from home.
The company will see people outside the medical field such as Aerospace, Pharma, Manufacturing.
Any company that deal with Materials, Chemistry.
Background in Polymer Chemistry
Develop new material
Someone that understands OSA regulations.
Deal with Lab scale process to Production scale process.
Material printing formulations
The company 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.
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.
- 5+ years’ experience preferred in material development for manufacturing in healthcare and/or medical devices ,but opened to other industries.
- 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 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