Sr Biomedical Engineer

Planet Pharma; Mounds View (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma is seeking a Biocompatibility Specialist to evaluate the safety and compatibility of medical devices with biological systems. You will plan and execute ISO 10993 testing, analyze data, and prepare regulatory submissions while supporting product development and post-market activities.

The role requires a University Degree and 4+ years of relevant experience, or an advanced degree with 2+ years.

Qualifications

• Experience in regulated industry and knowledge of biocompatibility regulations.
• Experience with assessing biocompatibility risk per ISO 10993 standards.
• 5+ years of relevant experience.

Responsibilities

• Design and place biocompatibility testing per ISO 10993 and regulatory guidelines.
• Collaborate with cross-functional teams to support product development and post-market activities from a biocompatibility perspective.
• Coordinate testing with laboratories to ensure compliance and resolve technical issues.
• Review test results and document findings for regulatory submissions.
• Stay current with evolving biocompatibility standards and regulatory expectations.

Skills

Regulated industry experience

ISO 10993 knowledge

Biocompatibility risk assessment

Education

University Degree

Advanced degree

Job description

1. 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.
2. 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.
3. What products (if any) will this role support? All products across EPT (CRM and CAS)
4. What is your target years of experience? 5+ years

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.

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.

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