Device Engineer I
New Today
The opportunity
We’re seeking a motivated early-career engineer to join our Combination Product Development team as a Device Engineer. This role offers hands-on experience in developing and testing drug delivery systems—including prefilled syringes, auto-injectors, and on-body injectors—within a regulated, cross-functional environment. Ideal candidates will have a Bachelor’s degree in engineering and a strong technical foundation, with a desire to grow through design control practices, physical testing, and documentation to support regulatory filings and product quality.
How you’ll spend your day
· Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick systems.
· Set up, execute, and document testing activities in accordance with protocols and Good Documentation Practices (GDP).
· Support the development, verification, and validation of test methods under the guidance of senior engineers.
· Assist in the evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.
· Participate in basic root cause investigations of product or test method deviations.
· Contribute to technical reports, data summaries, and documentation for design verification and regulatory submissions.
· Collaborate with cross-functional teams including QA, Regulatory, and Manufacturing to support development activities.
· Learn and apply relevant quality and regulatory standards (e.g., ISO 13485, ISO 14971, 21 CFR Part 820) in daily work.
Your experience and qualifications
Required Qualifications
· BS in Mechanical Engineering, Biomedical Engineering or a related field
· 0-2 years Medical Device or Combination Product experience
· Strong academic foundation in engineering principles and an interest in medical device or drug delivery systems including a good foundation in solid mechanics, mechanical design and fluid dynamics..
· Some hands-on lab experience (academic, co-op, or internship) with physical testing or mechanical systems.
· Ability to follow protocols and standard operating procedures.
· Effective written and verbal communication skills.
· Eagerness to learn in a collaborative and regulated environment.
Preferred Qualifications:
· Internship or cooperative experience in the pharmaceutical, biotech, or medical device industry.
· Exposure to regulated environments or quality systems (e.g., ISO 13485, GMP).
· Familiarity with Microsoft Excel, basic statistical tools, or mechanical test instruments.
· Experience in mathematical modeling and finite element analysis
· Experience in statistical analysis for medical devices
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
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment
- Location:
- West Chester
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