Senior Scientist I, Engineering - Design Verification Engineer

We are looking for an experienced Senior Scientist I, Engineering – Design Verification Engineer to join our Combination Product Development & Drug Delivery Team to contribute to the development of exciting new drug / device combination products.  As a Senior Scientist I, Engineering – Design Verification Engineer you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. If you are a self-motivated & communicative person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity might be for you.  Responsibilities:  • Serve as Subject Matter Expert (SME) on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.   • Responsible for equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.   • Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing. Support investigations and issue resolutions. Present results to cross-functional teams.   • Utilize volumetric accuracy equipment and force testing machine. Familiarity with Zwick, viscometers, climate chambers, etc. is a plus.   • Support data analysis using statistics, experience with MiniTab is a plus.   • Develop, validate, and transfer test methods.   • Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.   • Experience with SolidWorks, Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred.   • Work in an independent manner under the guidance of a supervisor or technical lead.  • Comply with applicable policies and procedures, regulatory and safety requirements.  • Work on cross-functional teams including Quality, Regulatory Affairs, Clinical Team, and global partners  • Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent education and 10+ years of experience, Master’s Degree or equivalent education and typically 8+ years of experience, PhD and 0+ years of exp.  • 3+ years of experience in medical device or combination products is required. Experience with design control, risk management, and regulatory standards including ISO compliance, FDA and ASTM standards, and regulatory knowledge.  • Knowledge of Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations.  Preferred Qualifications  • Significant experience and understanding of development and verification of complex combination products such as On-Body-Delivery-Devices and continuous pumps  • Significant experience with operation and maintenance of a Universal Test Machine (UTM), preferably Zwick  • Strong communication skills (both written and verbal) including the ability to influence without direct authority and ability to present to auditors on equipment qualification and data integrity.  • Regulated device testing processes, including detailed verification and validation methodologies. Documentation experience including technical reports, design verification plans, protocols, etc.  • Strong understanding of engineering fundamentals with strong problem solving and analytical skills.  • Knowledge in basic statistics and Six Sigma statistical techniques is a plus.  • Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams, strong decision making, and completing quality deliverables on time.  ​Applicable only t