Sr Staff Device Engineer

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Benefits offered by this job

Comprehensive Healthcare

401(k) with company match

Health & Wellness programs

Generous vacation time

Community outreach

Family planning support

Flexible working

Tuition reimbursement

Job summary

Takeda is seeking a Commercial Device Technical Lead in Lexington, MA to drive lifecycle management of drug delivery devices. You will work with cross-functional teams across manufacturing, QA, regulatory, and program leadership to ensure successful tech transfer and post-market activities.

The role emphasizes design controls, risk management, and strong problem solving in a fast-paced environment, with opportunities to lead high-impact device programs within the Takeda device development

Qualifications

• SME in medical devices, especially drug delivery systems.
• Experience leading drug delivery device products to commercialization.
• Knowledge of design controls and quality systems (ISO 13485, MDR).
• Strong problem solving and cross-functional collaboration.

Responsibilities

• Lead lifecycle management of commercial device products.
• Coordinate tech transfer of verification/validation activities.
• Support change control, MDR, and post-market surveillance.
• Oversee risk management and CAPA activities.
• Draft technical content: user requirements, protocols, reports.

Skills

Technical leadership

Cross-functional

Risk management

Design controls

cGMP knowledge

Regulatory guidance

LCM - life cycle management

Quality system knowledge

Root cause analysis

CAPA

Tech transfer

Test method development

Education

PhD in Mechanical / Electrical / Biomedical Engineering

Master’s with experience

Bachelor’s with experience

Tools

Design verification tools

Documentation systems

Job description

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.

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

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.

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.