Associate Engineering Fellow, Combination Product Development

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Job Description
OBJECTIVE:
The Associate Engineering Fellow will lead Takeda's cross-functional combination product development efforts for use in clinical studies and for commercial release. The ideal candidate will be a hands-on technical leader, considered a combination device subject matter expert (SME), providing project and engineering leadership 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, regulatory submission authoring, general project team technical support, and extensive collaboration with both internal and external partners. The individual is an expert in an Engineering Discipline in its entirety and be able to lead 2 or more programs in parallel.
ACCOUNTABILITIES:

• Manage and provide project and technical leadership to cross functional teams for projects through clinical development, product registration and launch-readiness. Will have technical responsibility for multiple projects.
• Establish and maintain the DHF, associated project plans, assess and mitigate technical risks and recommend / implement contingency plans as required.
• Lead the project execution in compliance with design control SOP. Oversee technical aspects of the development process including pertinent DHF deliverables, statistically sound design verification protocols/reports, design validation activities, and support production of materials for Clinical and Human Factors studies.
• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
• Support the optimization of design control elements to comply with combination produce/medical device regulations. Lead or assist in deviation, complaint and failure investigations.
• Author regulatory Common Technical Document (CT) to support submission.
• Mentor engineering staff within and outside of own discipline.
• Generate and present technical information to multidisciplinary audiences (internal/external) and levels.

EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
Required:

• A Bachelor of Science degree in Engineering is required, a Master of Science preferred.
• Bachelors and 15+ years relevant experience, Masters and 13+ years or PhD and 7+ years preferably within the biopharmaceutical industry or medical device development and commercialization are desired.
• Minimum of 7 years cross functional leading teams and projects.
• Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820), ISO13485, IEC 62304 and ISO14791 requirements.
• Proven track record of developing and gaining regulatory approval of medical devices and/or drug delivery systems.
• Experience with combination products requiring reconstitution and/or use of ancillary as a delivery solution. Large volume technology experience is highly desirable.
• Experience with in silico development is highly desirable.
• Strong collaboration, proven technical leadership and conflict resolution skills with a track record of delivering products to the market.
• Design for Six Sigma (DFSS) certification is desirable.
• Prior experience leading projects that include managing external design, development, and manufacturing partners.
• Knowledge of process validation and design transfer preferred.

Knowledge and Skills:

• Strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO 14971.
• Extensive knowledge of engineering principles, concepts and applications.
• Working knowledge of ISO 11608-1, IEC 60601-1 and collateral standards and other related standards.
• Ability to both lead as well as support as a technical individual contributor.
• Strong planning and organizational skills.
• Excellent writing and oral communication skills.
• Knowledge of project management techniques, tools and metrics. An aptitude for project foresight and contingency planning.
• Ability to mentor technical and cross functional team members.
• Strong collaboration skills with external partners.

TRAVEL REQUIREMENTS:
May require approximately 10% travel.
LINE FUNCTION SPECIFIC QUALIFICATIONS

• Provide technical leadership on multiple projects in parallel as well as across the organization.
• Drive the evaluation of complex drug delivery systems and provide sound technical recommendations 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:
$153,600.00 - $241,340.00
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
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.