Planet Pharma
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Biomedical Engineer II
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Planet Pharma 2 days ago Be among the first 25 applicants Join to apply for the
Biomedical Engineer II
role at
Planet Pharma 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
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Biomedical Engineer jobs in
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Biomedical Engineer II
role at
Planet Pharma 2 days ago Be among the first 25 applicants Join to apply for the
Biomedical Engineer II
role at
Planet Pharma 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
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Biomedical Engineer jobs in
Mounds View, MN . Manufacturing Engineer II - Medical Device
Biomedical Engineer (Application Consultant)
Process Engineer - Medical Injection Molding
Minneapolis, MN $100,000.00-$125,000.00 3 days ago Associate Quality Engineer - Medical Device
Greater Minneapolis-St. Paul Area $30.00-$33.00 4 weeks ago R&D Mechanical Engineer - Medical Device
Biomedical Engineering Department Head (with Faculty Rank)
Sr. Clinical Engineer - EP Mapping Specialist
St Paul, MN $75,300.00-$150,700.00 22 hours ago Non-Tenure Track Teaching Faculty Position, Biomedical Engineering - Open Rank
Senior & Principal Electrical Engineer - Medical Device
Minneapolis, MN $125,000.00-$150,000.00 1 week ago Assistant, Associate, or Full Professor - Medical Imaging (Full or Part-Time)
Mechanical Engineer - Medical Device Leads #3664
Sr Packaging Engineer - Medical Device Industry
Minneapolis, MN $105,000.00-$120,000.00 1 day ago Embedded Software Test Engineer – Control Algorithms (Medical Devices)
Minneapolis, MN $75,000.00-$77,000.00 1 hour ago Software Engineer - Medical Device -Android/IOS
Field Service Technician - North East Region
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr