Sr. Research Engineer II

Job Summary

Principal Duties and Responsibilities:

• Identify, assess, and support the remediation of existing orthopedic products
• Support development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
• Contribute biological safety content and supporting rationale technical documents.
• Conduct biocompatibility assessments and organize required biological safety testing.
• Support development of testing strategies and biological safety risk assessments for orthopedic products.
• Present scientific and technical information to internal groups and stakeholders, as necessary.
• Develop materials for project updates, technical reviews, and data presentations.
• This is not intended to be an exhaustive list of duties and may not include all essential functions of the role.

Expected Areas of Competence (i.e., knowledge, skills and abilities)

• Strong foundation in biological safety (ISO 10993) and orthopedic device manufacturing/quality/regulatory requirements.
• Strong foundation of internal and external training in area of biological safety.
• Demonstrated ability to present preclinical and scientific data clearly, credibly, and persuasively to stakeholders.
• Ability to communicate complex scientific concepts in a clear, concise, and audience appropriate manner.
• Strong and independent problem-solving skills, including the ability to evaluate complex situations, identify practical solutions, and execute effectively in a timely manner.
• Demonstrated ability to expand current knowledge, methods, and procedures and establish approaches that others can build upon.
• Ability to balance cross-functional priorities to meet customer expectations and project timelines.
• Effective use of resources, sound judgment, and strong execution skills.
• Demonstrated professionalism and ability to represent the company effectively, including in challenging or conflicting situations.
• Strong negotiation and collaboration skills related to scope, design, process, and timelines.
• Strong written, verbal, and presentation skills, with the ability to respond confidently to scientific and regulatory questions.
• Ability to discuss complex topics with confidence and credibility.
• Ability to communicate sensitive or complex information effectively with stakeholders.
• Demonstrated leadership, initiative, and accountability.

Education/Experience Requirements

• Bachelor's degree in a relevant scientific discipline required; Master's preferred.
• Relevant disciplines may include, biomedical science, biology, toxicology, materials science, or a related field.
• Typically requires: Master's degree with 3+ years of relevant industry experience,
• or Bachelor's degree with 5+ years of relevant experience.
• 3+ years of experience in medical device R&D with responsibility for biological safety risk assessment, or equivalent depth of experience based on degree level.
• Experience with successful project management is preferred.
• Experience supporting regulated product development and cross-functional research programs is preferred.