Lead, Device Engineering at Takeda Development Center Americas, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

Primary Duties

This role provides functional leadership to the activities and device engineering (hardware) personnel who are responsible for development (hardware), process and packaging engineering activities within the Plasma Derived Therapies (PDT) Device and MedTech Development (DMD) team. In addition this role will have oversight of the activities, personnel and equipment associated with PDT activities in the device lab.

The role is responsible for hiring and managing team personnel as well as acquiring and maintaining the budget required for the operation and development of the device engineering team as well the PDT ownership of the lab.

Responsibilities

• Functional management of the device engineering team


• Mentor and foster team members to reach their fullest potential while meeting organizational objectives


• Ensure that the budgetary needs of the device engineering team are met and communicated appropriately.


• Constant monitoring the optimize the team operation for efficiency and setting them up for success to deliver on the goals.


• Monitor the health of the device engineering activities across various programs and workstreams to evaluate if the team members are working on the right priorities and in alignment with Takeda's values; Provide course corrections if they are not.


• Closely collaborate with the Device Development leads (DDL) and Device Development Portfolio Leads (DDPL), Human Factors/User Experience, software development and other closely aligned functions within the DMD team


• Collaborate with Device Quality, Formulation/Fill/Finish, drug process development, Regulatory, commercial marketing, clinical, Global Program Leads/managers and other Takeda functions to deliver on organizational goals


• Manage and collaborate with external stakeholders such as CDOs, CMOs, test labs, consultants and others to ensure smooth operation of programs from an engineering management perspective.


• Drive the capability of the engineering team to build on technical and scientific knowledge with a goal to be industry-leading


• Collaborate with other functions within Takeda, academia, and other organizations to drive programs and initiatives to build on engineering as well as scientific innovation

Education and Experience Requirements

• The team leader must have 10+ years of medical device product development engineering experience with at least 2 years of experience directly managing people.


• Experience in development of devices related to drug administration is desirable.


• A Bachelor's degree in an engineering or relevant discipline is required. Master's degree is preferred


• A successful track record of developing employees and team members is required


• Extensive experience in the entire product development lifecycle bringing forward novel devices through US or EU approval

Key Skills, Abilities, and Competencies

• Strong track record around technical and engineering activities related to device development. Deep knowledge around design controls and risk management frameworks


• The leader must be comfortable with working in a fast-paced environment and comfortable with ambiguity


• Must show examples of strong leadership and collaboration with multi-disciplinary teams


• This is a key role within the DMD, and the incumbent must be creative, courageous, collaborative, and empowering.


• The team will be located in Lexington, MA and will co-operate with partners globally: ability to define a cohesive culture based on Takeda's values is critical.


• Takeda PDT not only develops devices inhouse but collaborates with external partners for design, development, and manufacture of novel devices. A strong interface management is therefore key to success.

Complexity and Problem Solving

• Solid understanding of engineering and analytical techniques related to product design, testing, root cause analysis, statistical methods, and risk management


• Be proficient in diving deep into an issue to make tactical decisions while having the ability to think at high-level during strategic decisions


• Foster consensus building within the team and organization while being decisive when needed


• Knowledge around product development of medical devices that allows them to identify areas of organizational and business process deficiencies and take the steps necessary to address them

Other Job Requirements

Up to 15% travel. Domestic and international

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