As a Principal Device Engineer we are seeking an experienced and versatile engineer to join our combination product development team. This role blends hands-on technical investigation of functional performance with end-to-end development of prefilled syringes (PFS), auto-injectors (AI), on-body injectors, and other delivery systems for biologics. You will lead root cause investigations into issues such as out-of-trend (OOT) high break-loose/extrusion force and injection time failures, while also contributing to the design, verification, and regulatory lifecycle of drug-device combination products under ISO 13485 and 21 CFR Part 4. The ideal candidate has strong mechanical aptitude, working knowledge of biologic drug product and container-closure interactions, and experience with design controls, method validation, and regulatory submissions. How You'll Spend Your Day Technical Investigation & Root Cause Analysis • Lead root cause investigations into device performance (e.g., high injection forces, needle clogging, high injection time, extrusion force variability). • Develop injection time and force models using first principals. • Experience with using laboratory instruments such as Instron/Zwick tensile testers, silicone coating analyzers (ZebraSci, RapID), Keyence Microscope, CT Scanner. • Perform sensitivity analysis of various parameters impacting injection time and injection force (e.g. viscosity, syringe and barrel dimensions, siliconization, fill volume, etc.) • Review IPC/QC data for trends and stratify failures by lot, component, or fill-finish process. • Lead the development of engineering test strategies and statistically sound test matrices to characterize product performance, establish design robustness, evaluate manufacturing variation, and support regulatory submissions and lifecycle management activities. • Partner with QA, manufacturing science, and suppliers to develop data-driven corrective actions. • Demonstrated ability to perform rigorous first-principles analysis of complex technical problems, identify underlying mechanisms and root causes, and develop data-driven solutions in the absence of established precedents. • Demonstrated ability to conduct technical deep dives across product design, manufacturing processes, and system performance, utilizing first-principles engineering analysis to identify root causes, assess risk, and establish scientifically sound recommendations. Combination Product Development • Lead or support the development of PFS, Autoinjectors, On-body injectors, and other devices under formal design control processes. • Author or contribute to design input requirements, risk analyses (per ISO 14971), and design verification protocols. • Develop and validate physical test methods for device functionality (PFS, Autoinjectors and On-Body Injectors) • Provide technical inputs to the selection and evaluation of device components and suppliers. • Development and validation of container closure integrity analytical test methods. • Interface with Human Factors, Regulatory Affairs, and external partners for technical alignment. Regulatory Support • Support technical sections of combination product filings, including BLA, MAA, NBO, and design history file documentation. • Prepare and review reports for design verification, test method validation (TMV), and deviation investigations. Staff Support • Demonstrated passion for mentoring and developing engineers through technical coaching, knowledge sharing, and constructive feedback, fostering a culture of continuous learning and engineering excellence. Your Skills and Experience • BS in Mechanical Engineering, Biomedical Engineering or a related field • Minimum 4 years of pharmaceutical, biotech, or medical device experience • Demonstrated experience with solids mechanics, systems design, fluid dynamics. • Mathematical modeling using first principals and Finite Element Analysis • Strong understanding of design controls per 21 CFR Part 820, ISO 13485, and risk management per ISO 14971. • Hands-on experience with design verification testing, method development and validation, and component qualification. • Familiarity with regulatory expectations for combination products, including technical sections of BLAs or MAAs. • Proficiency in data analysis tools (e.g., Minitab, JMP) and strong technical writing skills Also Good to Have • Experience with PFS, auto-injector or on-body injector platforms. • Familiarity with biologics interaction with primary container components and compatibility. • In-depth experience in container closure integrity testing and validation using technologies such as dye-ingress, headspace analysis, HVLD, He-Leak etc. • Understanding of Boyle's law/ideal gas equation and its application to plunger stopper movement during high altitude transit • Demonstrated experience in statistical analysis for medical devices (e.g. Gage R&R, sample size, tolerance interval analysis) • Exposure to human factors, usability engineering, or design validation under simulated-use conditions. • Track record of authoring technical content in regulatory submissions (IND, BLA, MAA). How We'll Take Care of You We offer a competitive benefits package, including: • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. • Life and Disability Protection: Company paid Life and Disability insurance. • Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. Make sure to apply through our internal career site on Twist-your one-stop shop for career development