Sr Staff Device Engineer

Takeda; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Benefits offered by this job

Healthcare (Medical, Dental, Vision)

401(k) with company match

Annual Retirement Contribution Plan

Onsite flu shots and health screenings

Generous vacation time off

Charitable contributions matching

Family planning support

Flexible working arrangements

Tuition reimbursement

Job summary

Takeda is seeking a Sr. Staff Device Engineer in Lexington, MA to act as the device SME for on-market combination products.

You will lead lifecycle management, change controls, and manufacturing validation while coordinating with drug product, quality, and regulatory teams in a cross-functional environment. You will oversee device qualification, tech transfer, CAPA and post-market surveillance, ensuring compliance with cGMP and ISO standards for drug delivery devices.

Qualifications

• PhD with 3+ years, MS with 5+ years, or BS with 8+ years related experience.
• SME in medical devices, especially drug delivery systems, with technical leadership.
• Knowledge of design controls and quality system requirements.
• Experience in lifecycle management for combination products including complaint handling and change control.
• Knowledge of cGMP and regulatory guidance for device/combination products.

Responsibilities

• Lead lifecycle management for commercial combination products as device SME.
• Coordinate tech transfer, verification and validation for new drug delivery devices.
• Provide input on change controls, MDR and post-market surveillance reports.
• Lead risk management activities and project work within defined budgets.
• Oversee device qualification processes and manufacturing expansion activities.

Skills

Medical devices expertise

Drug delivery systems

Design controls

cGMP compliance

Cross-functional collaboration

Technical leadership

Education

PhD in Mechanical, Electrical or Biomedical Eng

MS in related field

BS in related field

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.

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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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 YesIt 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.