Research Sr Engineer II- #26-26271

You could be just the right applicant for this job Read all associated information and make sure to apply.

• Responsible for supporting investigation and research activities for orthopedic products.
• This role supports research planning, study execution support, and outcome tracking, biological evaluation, and risk assessment documentation to support product remediation and regulatory objectives.
• Collaborates across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to support broader project needs.

• 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.

• 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.

• 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.

• 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.

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. xhyhwjd