Hybrid Control Design Engineer – Medical Devices

Fusion Life Sciences Technologies LLC; Warszawa; Híbrido; PLN 432.000 - 589.000; Jornada completa

Descripción de la vacante

Fusion Life Sciences Technologies LLC is seeking a qualified engineer to harmonize design controls and risk management for a medical device integration. You will support cross-functional teams, author remediation protocols, and potentially lead feasibility workstreams in new product development and manufacturing transfers.

Responsibilities include planning, coordinating deliverables with partners, developing specifications, and obtaining cross-functional approvals for design control, risk

Formación

• Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent.
• ABET-accredited school in Mechanical/ Biomedical/ Bioengineering/ Materials/ Chemical/ Polymer Engineering or related field strongly preferred.
• 3-5 years of full-time engineering experience in regulated medical device product development preferred.

Responsabilidades

• Harmonizes design controls and risk management procedures from a new acquisition with global processes.
• Supports integration activities by authoring remediation protocols and guiding integration strategy decisions.

Conocimientos

Communication skills

Regulatory knowledge

Statistics in engineering

Educación

ABET-accredited engineering degree

Engineering degree in Mechanical/Biomedical/Materials fields

Descripción del empleo

Fusion Life Sciences Technologies LLC is seeking a qualified engineer to harmonize design controls and risk management for a medical device integration. You will support cross-functional teams, author remediation protocols, and potentially lead feasibility workstreams in new product development and manufacturing transfers.

Responsibilities include planning, coordinating deliverables with partners, developing specifications, and obtaining cross-functional approvals for design control, risk