Staff Electrical Engineer - Electromechanical Systems応募後で応募 求人ID R0064812 掲載日 04/22/2022 Location:Lexington, Massachusetts
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Staff Electrical Engineer where you will support Takeda's electromechanical device development efforts for combination products used in clinical studies and for commercial releases. You will be a hands-on technical individual, 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 software-controlled electromechanical delivery systems. Areas of focus will include translating user needs to 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.
How you will contribute:
Provide technical leadership/support on cross functional teams for devices through clinical development, product registration and launch-readiness. Conduct feasibility and preliminary design verification testing to comply with medical device and combination product regulations.
Lead or assist in deviation, complaint and failure investigations.
Lead/support the project execution in compliance with design control SOP. Own/oversee some technical aspects of the development process and the development of statistically sound design verification protocols/reports and design validation.
Establish and maintain the design history file and associated project plans. Assess and mitigate technical risks and recommend/implement contingency plans as required.
Champion and apply Systems engineering principles in development and support continuous process improvement.
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
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, Manufacturing, 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
BS or MS in Electrical Engineering or equivalent.
More than 5 years experience for BS in the field of medical device or combination product development and commercialization is desired. Wearable or infusion pump experience is preferred.
Strong Electrical Engineering discipline training is required.
Demonstrate deep understanding of electronics circuit design theories.
Lab skills for measurement using various instruments required.
Knowledge of design for manufacturing/testing .
Familiarity with UL/CSA/TUV/CE requirements .
Design for Six Sigma (DFSS) certification is desirable.
Prior experience supporting projects that include managing external design, development, and manufacturing partners.
Good 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 IEC 60601-1 and other related standards.
Experience with wireless communication protocols.
Ability to both lead as well as support as a technical individual contributor.
Knowledge of project management techniques, tools and metrics. Experience with project foresight and contingency planning.
Strong collaboration skills with external partners.
May require approximately 10% travel.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Absent an approved religious or medical reason, all US field-based employees must be fully vaccinated for COVID-19, as a condition of employment.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.