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Job type: Permanent

Discipline: Administrative, General Management, Project Management

Location: United States

Proclinical is currently recruiting for a Medical Device Project Manager with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

Lead the execution of medical devices and packaging projects, ranging from various route of administration like SC, IM, IV, Intrathecal and supporting patient-centric, safe, reliable and innovative devices, digital devices and packaging technology projects, aligned to the drug pipeline, as well as execute, communicate deliverables, plans with internal stakeholders and external partners.
Lead cross functional teams to drive key activities throughout development phases of device and combination products, and facilitate the deliverables to support regulatory filing, product launch and post market surveillance.

Skills and Requirements:

10+ years' experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly.
Bachelor's Degree in Engineering required, Master's Degree or MBA with mechanical or related engineering discipline preferred and 10+ years' experience.
Deep understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies.
Deep knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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