Descripción y detalle de las actividades
The Senior Engineer position in the Vascular Access Product Engineering group is responsible for managing the post launch life cycle for products that have been released for sale. This includes analyzing change requests and implementing a change management plan, investigating and correcting non-conforming events, including Corrective Actions and Preventative Actions, remediating design history files to conform to new regulatory requirements, and developing line additions to expand the scope of a product portfolio. The Senior Engineer works on projects/matters of advanced complexity with cross functional support and often works independently of managerial staff.
**Essential Duties & Responsibilities**
- Organizes, plans, and executes activities related to implementing design changes per change management plans and company procedures.
- Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
- Updates design output documents such as engineering drawings, purchasing specifications, and bill of materials.
- Completes risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
- Provides technical support to regulatory, sales,



marketing and other functional areas as needed.
- Helps lead investigations of root causes leading to non-compliance events arising from design, manufacturing, procedural or customer use.
- Provides technical support as a Subject Matter Expert for a particular Product Family
- Works on special projects as assigned.
- Mentors junior members of the engineering staff including interns and/or cooperative students, or co-ops
Experiência y requisitos
- Bachelor’s degree in mechanical or biomedical engineering from an accredited college or university is required.
- 7-10 years of experience similar role in medical device manufacturing industry.
- Advanced Bilingual English/Spanish communication skills (Verbal and written)
Beneficios
- Guardería
- Utilidades garantizadas
- seguro de vida
- caja de ahorro
- comedor
- fondo de ahorro
- transporte
- seguro de gastos médicos
- plan de indexación
- servicios médicos en planta
**Número de vacantes** 1
**Área** Ingeniería
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
- Turno Matutino
- Lunes a viernes
**Estudios** Carrera con título cualificado
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** Si

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