Job ID SR0033395 Date posted 06/11/2019 Location Lexington, Massachusetts
The Lead Device Development Engineer will lead Takedas cross functional Combination Device Development efforts specific to prefilled syringes and auto-injectors. The ideal candidate will be a hands-on technical leader, considered a device subject matter expert (SME), and will provide project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for prefilled syringe and auto-injector systems. Area 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.
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. - 20%
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. - 25%
Support the optimization of design control elements to comply with medical device regulations. Lead or assist in deviation, complaint and failure investigations. - 5%
Education & Experience Requirements:
More than 10 years experience in the field of medical device or combination product development and commercialization is required.
Prefilled-syringe and or auto-injector experience is preferred.
A Bachelors of Science Degree in Engineering required, a Masters of Science Degree preferred.
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, and ISO14791 requirements.
Proven track record of developing and gaining 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 products to market.
Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences is expected.
DFSS certification is highly desirable.
Prior experience leading projects that include managing external design, development, and manufacturing partners.
Key Skills and Competencies:
A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971.
Extensive knowledge of engineering principles, concepts and applications.
Ability to both lead as well as support as a technical individual contributor
Effective 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.
Other Job Components:
Complexity and Problem Solving
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.
Internal and External Contacts
Collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal.
Work closely with external design, development, and manufacturing partners.
Interact with external partners including testing laboratories, CROs and CMOs.
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 OpportunityShire, 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 AccommodationsShire, 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.