Senior Device Development Engineer (Waltham)

Compensation

: $94,360.00 - $141,170.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takedas long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the worlds leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. We are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us! What makes a successful member of our team? Check out the traits were looking for and see if you have the right mix. Recognized for our culture and way of working, were one of only select companies to receive Top Global Employer status for 2019. Opportunity Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we dofrom decision-making to interacting with patients. Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. A strong, borderless team, we strive together towards our priorities and inspiring mission. Recognized for our culture and way of working, were one of only 13 companies to receive Top Global Employer status for 2018. Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention. The Senior Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners. Responsibilities 50%: Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. 20%: Establish and maintain detailed project plans, define risks and recommend contingency plans as required. 20%: Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. 5%: Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 5%: Lead or assist in deviation, complaint and failure investigations. Education & Experience Requirements Minimum of 7 years experience in the field of medical device or combination product development and commercialization is required. Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale-up a plus. A Bachelors of Science Degree in Engineering required, a Masters of Science Degree preferred. Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO14791 requirements. Proven track record of developing and gain regulatory approval of drug delivery systems a plus Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..). Strong hands on technical leadership skills with a track record of delivering new products to market. Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences, is desirable. DFSS certification is highly desirable. Prior experience leading projects with external design, development and manufacturing partners. Working knowledge of solid works desirable. Other Requirements Some domestic and international travel may be necessary Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takedas Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - EEO is the Law Supplement - Pay Transparency Policy - Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-###-#### and let us know the nature of your request and your contact information. Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click Add to create your job alert. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Takeda Pharmaceuticals. Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
Associated topics: biochemistry, biophysics, fermentation, hereditary, metabolic, molecular, neuro, neurodegenerative, pain, pharmaceutical * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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