Biomedical Engineer IIPlanet Pharma • Mounds View, MN, US

Biomedical Engineer II

Planet Pharma • Mounds View, MN, US

1 day ago

Job type

Full-time

Part-time

Job description

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Job Description

Can you please confirm your top 3 skills sets required? Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility. Experience with assessing biocompatibility risk per ISO 10993 standards.
Can you please confirm the 3 main responsibilities / day to day activities required for this role? Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective. Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
What is your target years of experience? 5+ years

Job Description

Additional position details from the manager :

Can you please confirm your top 3 skills sets required? Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility. Experience with assessing biocompatibility risk per ISO 10993 standards.

Can you please confirm the 3 main responsibilities / day to day activities required for this role? Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective. Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.

What is your target years of experience? 5+ years

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.

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.

TECHNICAL SKILLS

Must Have

Bachelor's degree in materials science, chemical engineering, biocompatibility or a related technical field. Advanced degrees will also be considered.

Experience in a regulated industry.

Knowledge of international and domestic regulations associated with biocompatibility.

Knowledge of materials and interactions with the body and environment.

Knowledge of Microsoft applications (Excel, Word, Outlook)

Nice To Have

Demonstrated problem solving and critical thinking skills

Effective verbal and written communication skills

Technical understanding of the effect processing has on material properties and performance

The ability to work well under pressure

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Industries

Staffing and Recruiting

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Biomedical Engineer • Mounds View, MN, US