Staff Manufacturing Engineer, Consumables

This position is responsible for in-house and contracted manufacturing, manufacturing engineering, and equipment planning/engineering in accordance with the company's Quality System and customer requirements. The role will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and scalability for commercialization of single use device and consumable products.

Requirements

• BS in Engineering or related discipline and 8+ years of related experience
• Knowledge of and experience in pilot/production line set up and validation in Controlled Environment
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards
• Excellent communications skills (both written and verbal)
• Ability to work independently or in team setting
• Project management experience preferred
• Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations
• Experience working with ERP/MRP/Documentation control systems
• Understanding of contracts (supply, services, non-disclosures agreements, etc.)
• Skilled in the use of Microsoft office suite, especially Word, PowerPoint, Excel

Benefits

• 401k plan
• Health benefits
• Generous PTO
• Parental leave program