Strategic Lead, Medical Devices R&D Engineer

Cook Inc - Bloomington in

Bloomington (IN)

Sur place

USD 110 000 - 160 000

Plein temps

Il y a 2 jours

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Résumé du poste

Cook Inc - Bloomington in Bloomington, IN is seeking a Lead Research and Development Engineer to drive technical leadership on medical device programs. You will collaborate with cross-functional teams to translate clinical needs into robust designs, oversee design history files, and ensure compliance with ISO and FDA requirements.

The role emphasizes mentoring, project leadership, and a deep understanding of regulatory standards, with opportunities to influence product strategy and quality

Qualifications

Bachelor's degree in Engineering and 7 years' relevant experience.
Experience in Medical Device or regulated industry/adjacent experience.
Project/technical leadership experience.
Experience mentoring, guiding, and training employees.

Responsabilités

Lead medium to large projects/programs and coordinate with project teams.
Provide technical leadership across multiple projects within the area.
Identify focus areas for research with senior leadership and establish best practices.
Develop and maintain design history files and ensure design decisions meet customer needs.
Collaborate with physicians, product managers, and SMEs to develop innovative medical devices.

Connaissances

Analytical skills

Technical writing

Cross-functional collaboration

AI & data concepts

Formation

Bachelor's degree in Engineering

Master's or PhD advantageous

Description du poste

The role emphasizes mentoring, project leadership, and a deep understanding of regulatory standards, with opportunities to influence product strategy and quality

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