Principal Device Engineer

Tevapharm; West Chester (Chester County); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Job summary

Teva Pharmaceuticals is seeking a Principal Device Engineer to lead development of combination products (PFS, Autoinjectors, On-body injectors) and guide design controls and regulatory submissions. You will perform first-principles analyses, root cause investigations, and collaborate across QA, manufacturing, and suppliers.

Ideal candidates have 4+ years in pharma/medical devices, strong mechanical and analytical skills, and experience with container-closure interactions and regulatory

Qualifications

• BS in Mechanical Engineering, Biomedical Engineering or related field.
• Minimum 4 years in pharma/biotech/medical device.
• Experience with design controls per 21 CFR Part 820, ISO 13485, ISO 14971.
• Hands-on verification testing, method development and validation.

Responsibilities

• Lead root cause investigations of device performance issues.
• Develop and validate physical test methods for PFS/Autoinjectors.
• Support regulatory submissions and lifecycle documentation.
• Collaborate with QA, manufacturing science, and suppliers.

Skills

Mechanical aptitude

Biologics interaction knowledge

First principles analysis

Data analysis (Minitab/JMP)

Finite Element Analysis

Education

BS in Mechanical or Biomedical Engineering

Tools

Instron/Zwick tester

ZebraSci/RapID coating analyzer

Keyence Microscope

CT Scanner

TMV/test method validation tools

Job description

We Are TevaWe’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 ImpactAs 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 DayTechnical Investigation & Root Cause AnalysisLead 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 DevelopmentLead 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 SupportSupport 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 SupportDemonstrated 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 ExperienceBS in Mechanical Engineering, Biomedical Engineering or a related fieldMinimum 4 years of pharmaceutical, biotech, or medical device experienceDemonstrated experience with solids mechanics, systems design, fluid dynamics.Mathematical modeling using first principals and Finite Element AnalysisStrong 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 skillsAlso Good to HaveExperience 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 transitDemonstrated 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 YouWe 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.Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva’s Equal Employment Opportunity CommitmentTeva 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.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.