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
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