Sr Biomedical Engineer

Job Title: Sr Biomedical Engineer
Job ID: 28004
Duration: 24 Months
Location: 8200 Coral Sea Street NE, Mounds View Minnesota 55112
Pay Rate: $55-60.00/hr on W2

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 products (if any) will this role support? All products across EPT (CRM and CAS)

What is your target years of experience? 5+ years

When do you plan to start interviewing? Within a few weeks

Will you be looking to hire and start ASAP or will the start date be delayed? Delayed start. Need formal approval still.

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Onsite (Mounds View)

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.

Responsibilities may include the following and other duties may be assigned. Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. 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: Seasoned individual contributor. 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 performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires a 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.