Engineer III – Combination Product Development

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Job Description

OBJECTIVE:

The Engineer III will support Takeda’s combination product development efforts for use in clinical studies and for commercial releases.  The ideal candidate will be a hands-on technical individual, providing project and engineering support in device and/or system identification, feasibility, development, qualification and launch readiness for drug delivery systems.  Areas of focus will include translating user needs to product requirements and specification development, feasibility test development, in silico development, design verification and validation testing, risk assessments, DHF creation, general project team technical support, and extensive collaboration with both internal and external partners.

ACCOUNTABILITIES:

• Provide technical support on cross functional teams for devices through clinical development, product registration and launch-readiness. Independently conduct feasibility and preliminary design verification testing and create design control deliverables to comply with combination product regulations. Independently collects, manages, analyzes and interprets data using existing standard procedures, digital platforms and software tools. Support in silico activities to align with internal strategy to shorten development time and have combination products on market sooner – 50%

• Support the project execution in compliance with design control SOP.  Own/oversee some technical aspects of the development process and the development of statistically sound design verification protocols/reports and design validation. Support in maintaining the design history file and associated project plans. – 20%

• Support the assessment and mitigation of technical risks. Support/lead in failure investigations and root cause analysis. – 20%

• Apply Systems engineering principles in development and support continuous process improvement. – 10%

Education and Experience:

Required:

• A Bachelor of Science degree in Engineering is required, a Master of Science preferred.

• Bachelor’s and 2+ years relevant experience, Master’s degree preferably within the biopharmaceutical industry or medical device development and commercialization is desired.

• Hands on technical support and lab skills for measurement using various instruments required.

• Knowledge in creating design control/technical file deliverables.

• Prior experience supporting projects that include managing external design, development, and manufacturing partners.

• International travel required.

Knowledge and Skills:

• Awareness of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO 14971.

• Knowledge of engineering principles, concepts and applications.

• Awareness of global industry standards (ex: ISO, AAMI, ANSI, etc.).

• Self-starter with strong planning and organizational skills.

• Excellent writing and oral communication skills.

• Awareness of project management techniques, tools and metrics.

• Good collaboration skills with experience in presenting in front of an audience.

TRAVEL REQUIREMENTS:

May require approximately 10% travel.

LINE FUNCTION SPECIFIC QUALIFICATIONS

• Provide technical support on multiple projects in parallel.

• Drive the evaluation of drug delivery systems and provide technical summaries to move projects forward.

• Identify, communicate and lead device design control process evolution to meet device regulations.

• Collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement

• Work closely with external design, development, and manufacturing partners

• Interact with external partners including testing laboratories, CROs and CMOs

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:

$84,000.00 - $132,000.00

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.