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.

Employment type
Full-time

Work arrangement
No