Sr Biomedical Engineer - Exempt

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

Job summary

Lancesoft in Mounds View, MN is seeking a seasoned biocompatibility specialist responsible for evaluating the safety and compatibility of medical devices with biological systems. This role offers a collaborative environment and opportunities for professional growth.

You will design and execute ISO 10993-based assessment plans, coordinate with laboratories, review results, and support regulatory submissions and post-market activities.

Qualifications

• Minimum 4 years relevant experience with a Bachelor’s degree, or Master’s with 2+ years, or PhD with 0 years.
• Solid knowledge of ISO 10993 and regulatory requirements.
• Experience reviewing lab results and preparing regulatory submissions.
• Ability to design and execute biocompatibility assessment plans.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Design and execute biocompatibility assessment plans and reports per ISO 10993 and regulatory requirements.
• Coordinate testing activities with laboratories to ensure compliance and resolve issues.
• Review and interpret laboratory results; document findings for reports and submissions.
• Support product development lifecycle from a biocompatibility perspective.
• Stay current with global biocompatibility standards and regulatory expectations.

Skills

Biocompatibility

Regulatory awareness

Independent worker

Project leadership

Cross-functional collaboration

Education

Bachelor’s degree + 4+ years

Master’s degree + 2+ years

PhD + 0 years

Job description

We are seeking a seasoned individual contributor responsible for evaluating the safety and compatibility of medical devices with biological systems. This role is based in the vibrant community of Mounds View, MN, offering a collaborative environment and opportunities for professional growth.

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.

Responsibilities May Include

• Designing, developing, and providing safety testing, repair, and maintenance of biomedical equipment.


• Ensuring that biomedical equipment is in compliance with applicable regulatory requirements and quality control standards.


• Designing studies and conducting research on enzyme reactions and the effects of organic compounds on biological processes.


• Participating in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

Technical Specialist Career Stream This role involves formulating, delivering, and/or managing projects assigned and working with other stakeholders to achieve desired results. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies –from design to implementation – while adhering to policies, using specialized knowledge and skills.

Differentiating Factors

• Autonomy: Works independently under limited supervision to determine and develop approach to solutions.


• Coaches and reviews the work of lower-level specialists; may manage projects/processes.


• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.


• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance the performance of the job area.


• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision‑making.


• Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others"'work product.

Required Knowledge and Experience

• Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.