Principal Development Device Engineer - Electromechanical System at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Development Device Engineer – Electromechanical System 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. 

POSITION OBJECTIVES 

The Principal Development Device Engineer will lead Takeda’s cross functional Combination Device Development efforts for complex drug delivery programs used in clinical studies and for commercial releases.  The ideal candidate will be a hands-on technical leader, considered a device subject matter expert (SME), providing project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for electromechanical with software controlled delivery systems.  Areas of focus will include identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, risk assessments, DHF creation, general project team technical support, and extensive collaboration with both internal stakeholders and external development partners.

POSITION ACCOUNTABILITIES 

• Manage and provide project and technical leadership to cross functional teams for projects through clinical development, product registration and launch-readiness. – 30%




• Establish and maintain the DHF, associated project plans, assess and mitigate technical risks and recommend / implement contingency plans as required. – 15%




• Lead the project execution in compliance with design control SOP.  Oversee all technical aspects of the development process including pertinent DHF deliverables, statistically sound design verification protocols/reports, design validation activities, and support with Human Factors studies. – 20%




• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. – 15%




• Support the optimization of design control elements to comply with medical device regulations.  Lead or assist in deviation, complaint and failure investigations. – 5%

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




• Generate and present technical information to multidisciplinary audiences (internal/external) and levels. – 5%

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS 

Education Requirements: 

• More than 10 years experience in the field of combination product development and commercialization is required.  Auto-injector and/or infusion pumps experience is preferred.




• A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred. Strong knowledge of Electrical Engineering or Software Engineering a plus.




• Minimum of 5 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 containing hardware/software.




• Strong collaboration, proven technical leadership and conflict resolution skills with a track record of delivering products to 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.

LINE FUNCTION SPECIFIC QUALIFICATIONS

• Provide technical leadership on multiple projects in parallel.




• 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

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.




• Strong knowledge of the software development process and leveraging agile methodologies compliant to ISO 62304.




• Strong knowledge of embedded software architecture and design with a focus on real-time and safety critical software/firmware.




• Experience with debugging embedded software systems.




• Experience with wireless communication protocols.




• Knowledge of analog and digital circuits, microcontroller hardware and software and their development tools.




• Ability to both lead as well as support as a technical individual contributor.




• Strong planning and organizational skills.




• Excellent writing and oral communication skills.




• Strong 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 up to 10% travel

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 Programs

Empowering Our People to Shine

Discover more at takedajobs.com

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*This job posting excludes CO applicants*

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