Device Engineer II

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

For the Device Engineer II position we are seeking a motivated and technically curious engineer to join our Combination Product Development team. In this role, you will support the development and lifecycle management of prefilled syringes (PFS), auto-injectors (AI), on-body injectors, and other combination products for biologic therapies.

This is an ideal opportunity for a recent graduate (Master’s level) or early-career professional looking to build experience in medical device development under design controls (21 CFR 820, ISO 13485), design verification, and product performance evaluation. You will work alongside senior engineers on cross-functional teams, contribute to technical studies, and gain hands-on experience in a regulated environment.

How you’ll spend your day

Product Development Support:

· Assist in the execution of design control activities including user need translation, risk management, and design verification testing.

· Support technical evaluations of device components and assembly configurations (e.g., stoppers, barrels, needle shields, springs, plungers).

· Contribute to component and system-level testing of drug delivery devices to evaluate injection time, glide force, and dose accuracy.

Test Method Development:

· Assist in the development and qualification of physical test methods (e.g., for syringe functionality, BLE/glide force, injection time).

· Perform hands-on testing using force testers (e.g., Instron, Zwick), timers, and mechanical fixtures in the lab.

Documentation & Reporting:

· Document experimental work in technical reports, protocols, and lab notebooks with attention to Good Documentation Practices (GDP).

· Contribute to design verification protocols and reports under the supervision of senior engineers.

Investigations & Technical Support:

· Participate in root cause investigations of product performance deviations (e.g., high BLE force, long injection time).

· Analyze and summarize test data using statistical tools under guidance (e.g., JMP, Excel, or Minitab).

Cross-Functional Collaboration:

· Collaborate with peers in Regulatory Affairs, Quality, Manufacturing, and Analytical Development to support device development and submission readiness.

· Attend team meetings, present data, and learn cross-functional expectations for combination products.

Product Development Support:

· Assist in the execution of design control activities including user need translation, risk management, and design verification testing.

· Support technical evaluations of device components and assembly configurations (e.g., stoppers, barrels, needle shields, springs, plungers).

· Contribute to component and system-level testing of drug delivery devices to evaluate injection time, glide force, and dose accuracy.

Test Method Development:

· Assist in the development and qualification of physical test methods (e.g., for syringe functionality, BLE/glide force, injection time).

· Perform hands-on testing using force testers (e.g., Instron, Zwick), timers, and mechanical fixtures in the lab.

Documentation & Reporting:

· Document experimental work in technical reports, protocols, and lab notebooks with attention to Good Documentation Practices (GDP).

· Contribute to design verification protocols and reports under the supervision of senior engineers.

Investigations & Technical Support:

· Participate in root cause investigations of product performance deviations (e.g., high BLE force, long injection time).

· Analyze and summarize test data using statistical tools under guidance (e.g., JMP, Excel, or Minitab).

Cross-Functional Collaboration:

· Collaborate with peers in Regulatory Affairs, Quality, Manufacturing, and Analytical Development to support device development and submission readiness.

· Attend team meetings, present data, and learn cross-functional expectations for combination products.

Your experience and qualifications

Required Qualifications:

· BS in Mechanical Engineering, Biomedical Engineering or a related field

· 2-4 years Medical Device or Combination Product experience

· Foundational understanding of mechanical systems and materials, preferably with exposure to medical device or drug delivery systems through academic work or internships.

· Hands-on lab experience with mechanical testing, instrumentation, or materials evaluation.

· Strong attention to detail and ability to follow procedures and document results clearly.

· Good communication skills and willingness to learn in a regulated environment.

Preferred Qualifications:

· MS in Engineering

· 0-2 years Medical Device or Biopharma Combination Product experience

· Internship or co-op experience in medical devices, pharmaceuticals, or combination products.

· Familiarity with design controls (21 CFR 820, ISO 13485), risk management (ISO 14971), or test method validation (ICH Q2(R2), USP <1225>).

· Exposure to statistical analysis software (e.g., Minitab, JMP) or structured problem-solving tools.

Enjoy a more rewarding choice

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.   

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