Biomedical Engineer II
2 Days Old
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.
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
- Location:
- Saint Paul