Sr Biomedical Engineer at Planet Pharma Saint Paul, MN

Planet Pharma; Saint Paul (MN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Planet Pharma Group in Minnesota seeks an experienced biocompatibility specialist to evaluate safety and ISO 10993 compliance for medical devices. The role involves planning and placing biocompatibility testing, coordinating with laboratories, and preparing technical reports for regulatory submissions.

You will analyze data, support product development, and address biocompatibility issues during development and post-market activities, ensuring ongoing regulatory compliance.

Qualifikationen

• Experience in a regulated industry.
• Knowledge of international and domestic regulations associated with biocompatibility.
• Experience with assessing biocompatibility risk per ISO 10993 standards.

Aufgaben

• Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements.
• Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
• Review and interpret laboratory test results; document findings in technical reports and regulatory submissions.
• Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.
• Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance.

Kenntnisse

Regulated industry experience

ISO 10993 knowledge

Biocompatibility risk assessment

Ausbildung

University degree (relevant field)

Jobbeschreibung

Company & Location

Planet Pharma Group
Mounds View, MN

Position Description

The individual in this position is responsible for evaluating the safety and compatibility of medical devices with biological systems. The role involves planning and placing biocompatibility testing in accordance with ISO 10993 standards, regulatory guidelines, and risk assessment principles. This individual collaborates with cross-functional teams to ensure materials meet safety requirements. This individual analyzes data, prepares technical reports, and supports regulatory submissions. This position may also be involved in developing strategies for new products and addressing biocompatibility related issues during product development and post-market activities.

Required Skills

• Experience in a regulated industry.
• Knowledge of international and domestic regulations associated with biocompatibility.
• Experience with assessing biocompatibility risk per ISO 10993 standards.

Target Years of Experience

5+ years

Supported Products

All products across EPT (CRM and CAS)

Position Responsibilities

• Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements.
• Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
• Review and interpret laboratory test results; document findings in technical reports and regulatory submissions.
• Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.
• Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance.

Requirements

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.