Ideal Candidate: has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable. Proficiency in Microsoft Office is required, and CAD/SolidWorks skills are a plus. Entry-level candidates with practical experience, such as internships, are preferred, while overqualification (e.g., PhD or advanced degrees with extensive experience) is less desirable. Packaging engineering knowledge is a bonus but not mandatory.
Preferred Qualifications: • Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering) • Minimum 2 year of scientific or engineering experience in a GMP regulated environment • Statistical Analysis software (Minitab or JMP) • Strong technical writing skills • CAD fixturing software (SolidWorks) • Instron force tester using BlueHill Universal • Experience with design controls; including (but not limited to) verification and design transfer • Understanding of risk assessments including hazard and probability analysis • Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish) • Ability to work independently and dynamically across functional teams • Excellent written and verbal communication skills
Ability to support complex workstreams under demanding timelines