What are the responsibilities and job description for the Senior Principal Device Engineer position at Teva Pharmaceuticals?
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:
Your experience and qualifications
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
Important notice to Employment Agencies - Please Read Carefully
Teva 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.
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.
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.
- 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.
- 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
- 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.
- 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/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).
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
Important notice to Employment Agencies - Please Read Carefully
Teva 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.
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.
