Principal Device Engineer

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) matched

Paid time off

Life & disability insurance

Job summary

Teva Pharmaceuticals in the United States seeks a Principal Device Engineer to lead development of PFS, Auto-injectors, and on-body injectors for biologics within a regulated quality system.

You will conduct root-cause investigations, build first-principles models, and guide design verification, risk analyses per ISO 14971, and regulatory submissions.

Mentor engineers and collaborate with QA, Regulatory Affairs, and suppliers to deliver robust, compliant devices and lifecycle support.

Qualifications

• BS in Mechanical or Biomedical Eng or related field.
• 4+ years in pharma/biotech/medical device.
• Strong understanding of solids mechanics and design controls.

Responsibilities

• Lead root cause investigations into device performance (e.g., high injection forces, needle clogging, extrusion).
• Develop and validate test methods for device functionality (PFS, Autoinjectors, On-Body Injectors).
• Provide technical inputs for design input requirements, risk analyses, and verification protocols.
• Collaborate with QA, regulatory, and suppliers to implement data-driven corrective actions.

Skills

Solid mechanics

Design controls

First-principles analysis

Regulatory submissions

Education

BS in Mechanical or Biomedical Eng

Tools

Minitab

JMP

Job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

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.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.