Head of Device Design and Test Laboratory

Company: Takeda Pharmaceutical
Location: Hopkinton
Posted on: May 13, 2022

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head of Device Design and Test Laboratory in our Lexington, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.POSITION OBJECTIVES:

• Oversees and manages Takeda's internal medical device testing laboratory for testing of the device constituent part of combination products and medical devices used with Takeda's drug products.
• Leads a diverse team of engineers with focus on test development, test execution, and data analysis to support prototyping, concept design, and device verification testing throughout the product lifecycle, including support of on market products.
• Oversee device testing with external partners by coordinating testing requirements, ensuring test protocols are developed with sound engineering principals, and tracking progress to deliverables.POSITION ACCOUNTABILITIES: -
  • Provides overall direction and oversight to the medical devices testing laboratories at 125 Spring Street including test method development/validation, protocol/report writing, equipment calibration and preventative maintenance, and test execution. - Ensures that data collection and documentation meets requirements of internal SOPs and regulatory requirements.
  • Leads and drives resolution of technical issues related to device deviations, failure investigations, and complaint testing.
  • Manage external resources including contractors and consultants, as needed, to deliver on objectives.
  • Identifies, facilitates, and supports opportunities to enhance functional capability expansion and growth.
  • Drives and facilitates R&D/Pharm Sci initiatives including digital readiness, innovation, sustainability (green), and delivering on our commitments. -
  • Accountable for the achievement of critical goals that impact and contribute to the mission of Drug Product and Device Development.
  • Manages aspects of department performance (e.g. goal-setting, development and performance reviews, etc.), personnel issues, and effective communication within the group.
  • Able to influence and inspire engineers/scientists in the organization as well as be a strong mentor and coach.CORE ELEMENTS RELATED TO THIS ROLE:
    • Extensive knowledge/experience of developing and commercializing FDA regulated devices/combination products under Design Control (21 CFR 820) regulations and ISO 14971
    • Preparedness and responsiveness towards audits / inspections and compliance
    • Fosters and drives a culture that is innovative, encourages risk, and champions the development of its people.DIMENSIONS AND ASPECTS:
      • Extensive knowledge of engineering principles, concepts, and applications.
      • Direct hands on experience in test development and execution.
      • Proven track record of leveraging existing methods or standards and ability to develop new methods. Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).
      • Strong hands on technical leadership skills with a track record of delivering results.
      • Experience in statistical evaluations. Working knowledge of MiniTab or similar a plus.
      • Understanding of requirements for Equipment and Method Qualification / Validation and corresponding experience in execution of such.
      • An aptitude for project foresight and contingency planning.
      • Previous experience with 21CRF part 11, data integrity, and GxP is a plus.Leadership
        • Accountable for the achievement of critical goals that impact and contribute to the mission of Drug Product and Device Development.
        • Drives a culture of diversity, equity, and inclusion.
        • Leads and supports growth and development of team members.
        • Demonstrates ability to manage up and down the organization; Ability to use appropriate management strategies to provide direction for the work of team members and support individual development.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
          • A MS or Ph.D. in related engineering or scientific discipline with at least 10 years of experience in the field of testing of medical devices or combination products (development through commercialization).
          • Prior experience in leadership, management, and development of a high performing team. -
          • Prior experience in developing and testing electro-mechanical and software medical devices a plus.
          • Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO 14791 requirements.
          • Proven track record of leveraging existing methods or standards and ability to develop new methods. Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).
          • Experience in statistical evaluations.
          • Design for Six Sigma certification is desirable.
          • Understanding of GMP and GLP requirements.
          • Strong mentor and coach; invests time in helping others enhance their skills and perform at a higher level.
          • Excellent written and oral communication skills. Effective planning and organizational skills.ADDITIONAL INFORMATION: -
            • This is a laboratory-based position with on-site expectation of at least 4 days/week but with some flexibility.
            • Some domestic and international travel may be necessary.Updated Takeda U.S. Vaccine Requirement:Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. - US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.WHAT TAKEDA CAN OFFER YOU:
              • 401(k) with company match and Annual Retirement Contribution Plan
              • Tuition reimbursement
              • Company match of charitable contributions
              • 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-AA1EEO StatementTakeda 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.EEO StatementTakeda 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Worcester , Head of Device Design and Test Laboratory, Healthcare , Hopkinton, Massachusetts