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Drug Delivery Device Engineer Jobs (NOW HIRING)

Scorpion Therapeutics

NY · On-site

$99K - $136K/yr

Research, monitor, and analyze drug delivery system industry/market trends, competitive landscapes ... Device Development Engineer: 2+ years experience; Senior Device Development Engineer: 5+ years ...

Atomic

Drug CMC Lead

$150K - $215K/yr

... delivery system. This role requires deep expertise in regulatory CMC requirements (especially drug ... Partner with clinical operations, regulatory affairs, quality assurance, device engineering, and ...

ttg Talent Solutions

NY · On-site

$102K - $141K/yr

This hands-on role sits at the intersection of medical device engineering and pharmaceutical science, with a particular focus on inhalation and nasal drug-delivery systems, including dry powder ...

New

Regeneron Pharmaceuticals, Inc

NY · On-site

$99K - $136K/yr

Research, monitor, and analyze drug delivery system industry and market trends, competitive ... Device Development Engineer: 2+ years of experience * Sr. Device Development Engineer: 5+ years of ...

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Drug Delivery Device Engineer information

What does a drug delivery device engineer do?

A Drug Delivery Device Engineer designs, develops, and tests devices that deliver medications to patients in a safe and effective manner. This includes creating technologies such as inhalers, injectors, infusion pumps, and implantable systems. They work closely with multidisciplinary teams to ensure devices meet regulatory standards, are user-friendly, and optimize drug delivery for specific therapeutic needs. Their role also involves troubleshooting device issues, improving existing technologies, and staying updated on advancements in materials and biomedical engineering.

What are the typical challenges drug delivery device engineers face when working on new product development?

Drug Delivery Device Engineers often encounter challenges related to balancing regulatory requirements with innovative design. Ensuring the safety, efficacy, and reliability of devices while meeting strict FDA or international standards can be complex and time-consuming. Additionally, collaborating effectively with cross-functional teams—such as regulatory affairs, manufacturing, and clinical experts—is essential to address technical and usability concerns throughout the product lifecycle. Adapting to evolving technologies and user needs also requires continuous learning and flexibility.

What are the key skills and qualifications needed to thrive as a drug delivery device engineer, and why are they important?

To thrive as a Drug Delivery Device Engineer, you need a solid background in biomedical engineering, mechanical engineering, or a related field, often with a relevant degree and experience in medical device design. Familiarity with CAD software, regulatory standards (such as FDA and ISO 13485), and prototyping tools is typically required. Strong problem-solving, teamwork, and communication skills help you collaborate across multidisciplinary teams and address complex design challenges. These competencies ensure the safe, effective, and compliant development of innovative drug delivery devices that improve patient outcomes.

What are popular job titles related to Drug Delivery Device Engineer jobs?

For Drug Delivery Device Engineer jobs, the most frequently searched job titles are:

Sr Staff Device Engineer

Lexington, MA • On-site

Takeda Pharmaceutical Company Limited
Investment Clubs and Venture Capital Companies • 1 - 10 employees
Learn more about Takeda Pharmaceutical Company Limitedexternal

Full-time

Medical, Dental, Vision, Retirement

Posted 29 days ago

Takeda Pharmaceuticals rating

7.3

Company rating: 7.3 out of 10

Based on 71 frontline employees who took The Breakroom Quiz

Job description

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Sr. Staff Device Engineer where you will be recoganized as a device SME of combination product device on the Commercial Device Engineering (CDE) team accountable for all the technical aspects of the on-market combination product lifecycle management. You will also be responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. As part of the CDE team, you will report to Director, Commercial Device Engineering and work with external CLO and CMO.
The on-market combination products enhance patient and medical professional experiences with Takeda's medicinal drug products. In particular, the Sr. Staff Device Engineer has experience in drug delivery devices/systems and understanding of manufacturing process in global standards for the combination products.
How you will contribute:
  • You will work as commercial device technical lead working with cross functional team to support lifecycle management of commercial combination product.
  • This CDE position is within Takeda's Drug Product Device Development and will work closely with drug product, quality, regulatory, program leadership, etc. The successful candidate will work in a cross functional environment and establish strategic working relationships.
  • Conduct technical investigations, analyze technical aspects related to the manufacturing processes and/or commercial expansion.
  • Oversight of commercial device qualification processes, coordinate tech transfer of verification and validations related to technology transfer of new drug delivery devices, and solve technical issues related to commercial products.
  • Provide input to change controls, MDR, and post-market surveillance reports.
  • Lead gap assessments / remediation as needed and guide technical aspects of risk management activities. Lead products' projects within budget for defined activities.
  • Complaint handling including SME evaluation root cause analysis, CAPA, change control.
  • Design control process, specification creation, design verification and validation, design transfer, test protocol and report generation.
  • Manufacturing expansion, process validation.
  • Quality regulation system, DHF, MDR, ISO13485, ISO14971.
  • Ensured Compliance with appropriate device and combination product regulations and Takeda policies.

Minimum Requirements/Qualifications:
  • PhD degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with a minimum of 3 years of relevant experience; Master's degree with a minimum of 5 years of relevant experience; or Bachelor's degree with a minimum of 8 years of relevant experience.
  • SME in medical devices, particularly drug delivery systems, with technical leadership to manage drug delivery device commercialized products such as PFS, pen injector, Autoinjector, Needle Safety Device, etc.
  • Knowledge in design controls and quality system requirements.
  • Technical expertise in combination product with focus on life cycle management including complaint handling, change control, manufacturing expansion, and quality and regulatory supports.
  • Knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document and Regulatory combination product guidance documents applicable to the role. Strong problem solving skills, excellent communication and cognitive skills.
  • Good understanding of manufacturing process and packaging constructions methods. Ability to work in team, fulfills commitments and managing multiple stakeholders. Experience in drafting portions of combination product technical content. Proven ability to author user requirement specifications, technical protocols, reports and assessments. Previous project team experience with technology transfer. Hands on experience with the concept development and feasibility testing, test method development and test method validation.
  • Technical leadership for high performing teams, with strong ability to meet timelines, work effectively cross functionally and expertly advise key stakeholders.
  • Experience in medical device LCM: change controls, device complaint investigations and post-market surveillance

What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Flexible Ways of Working
  • Tuition reimbursement

Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

What Takeda Pharmaceuticals employees say

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About Takeda Ventures

Sourced by ZipRecruiter

Industry

Investment clubs and venture capital companies, pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

1 - 10 Employees

Headquarters location

San Diego, CA, US

Social media

Twitter

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