Job Details

ID #4501262
Estado Massachusetts
Ciudad Usma
Tipo de trabajo Contract
Salario USD TBD TBD
Fuente Infotree Service Inc
Showed 2020-08-06
Fecha 2020-08-03
Fecha tope 2020-10-02
Categoría Etcétera
Crear un currículum vítae

Sr Engineer(Drug Substance and Drug Product or Drug delivery devices)

Massachusetts, Usma 00000 Usma USA

Vacancy caducado!

Job Description

Candidate will be working on site3-5 years in Pharma or BiotechEducation - Bachelors in Engineering

Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities: - Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers. Skills: - BS in Engineering and previous experience in a medical device industry - 10 years current experience with engineering processes and procedures. - Led projects from development through the 510k and PMA approval process. - Strong background in engineering and commercialization of electro-mechanical medical devices. - Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. - Experience in drug/device combination product design and development - Familiar with the following standards: o Quality System Regulation 21CFR820 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment EN 60601 - Small scale device assembly experience. - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. - Strong problem solving, risk assessment, and risk management skills. - Must be capable of working on multiple projects in a deadline driven environment. VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered

Qualifications

Candidate will be working on site3-5 years in Pharma or BiotechEducation - Bachelors in Engineering

VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered

Additional Information

Top 3 Must Have Skill Sets:

1.Conducting technical assessments on process/product impact due to changes in equipment, scale, and raw materials.2.Providing technical support and lead troubleshooting of clinical and commercial drug substance manufacturing while performing technical review of data, and authoring and reviewing GMP documentation.3.Functioning as a technical specialist on equipment and/or systems regarding process design, scale-up, and troubleshooting operations

Vacancy caducado!

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