Senior Principal Device Engineer

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As a Sr. 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.
•    Partner with QA, manufacturing science, and suppliers to develop data-driven corrective actions.
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.

Your experience and qualifications

Required Qualifications:
•    BS in Mechanical Engineering, Biomedical Engineering or a related field
•    Minimum 10-14 years Medical Device or Combination Product 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.
Preferred Qualifications:
•    MS or PhD in Mechanical Engineering
•    Minimum 8-10 years Medical Device or Biopharma Combination Product experience
•    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/id