Research Principal Engineer I- #26-21710

US Tech Solutions; Warsaw (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

US Tech Solutions seeks a scientific investigator to lead and support research activities for orthopedic products. You will drive study planning, execution support, and risk assessments to align with regulatory objectives, collaborating with R&D, Regulatory Affairs, Clinical, Marketing, and Sales.

As a biomedical science expert, you will liaise with external KOLs, CROs, and labs, advancing neuro-related project needs while ensuring rigorous documentation and data quality throughout product

Qualifications

• Recognized expertise in biological safety (ISO 10993) and orthopedic device development.
• Ability to present preclinical data clearly to scientific and regulatory audiences.
• Strong communication and collaboration across R&D, regulatory, marketing, and clinical teams.

Responsibilities

• Lead and support investigation and research activities for orthopedic products.
• Develop study protocols, reports, and biological safety risk assessments.
• Coordinate laboratory studies and data presentations for regulatory submissions.
• Serve as technical liaison with external experts, CROs, and suppliers.
• Provide medical/scientific input to project teams and cross-functional partners.

Skills

Biological safety

Orthopedic product research

Scientific communication

Cross-functional collaboration

Job description

Responsible for leading and supporting investigation and research activities for orthopedic products. This role drives research planning, study execution support, and outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives. Serves as a scientific subject matter expert and advisor to cross-functional teams including R&D, Marketing, Sales, Clinical Affairs, and Regulatory Affairs. Acts as a key scientific liaison with external key opinion leaders, laboratories, suppliers, CROs and partner organizations. Collaborates across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to advance research initiatives and support broader neuro-related project needs.

Duration: 12 months

Job Summary:

Responsible for leading and supporting investigation and research activities for orthopedic products. This role drives research planning, study execution support, and outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives. Serves as a scientific subject matter expert and advisor to cross-functional teams including R&D, Marketing, Sales, Clinical Affairs, and Regulatory Affairs. Acts as a key scientific liaison with external key opinion leaders, laboratories, suppliers, CROs and partner organizations. Collaborates across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to advance research initiatives and support broader neuro-related project needs.

Principal Duties and Responsibilities

• Identify, assess, and support the development of new and existing orthopedic products
• Lead or support development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
• Develop strategy for technical investigations and provide scientific expertise to the research team and other cross-functional partners.
• Contribute biological safety content and supporting rationale for regulatory submissions and related technical documents.
• Serve as a subject matter resource for biological evaluation activities related to new product development and sustaining products across the portfolio.
• Coordinate, initiate, track laboratory studies and associated deliverables.
• 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, stakeholders, and regulatory bodies as necessary.
• Provide medical and scientific expertise to project teams, marketing, global sales, and medical information functions, as needed.
• Develop materials for project updates, technical reviews, and data presentations.
• Support relationships and scientific interactions with key opinion leaders and external collaborators.
• Contribute to additional neuro-related research activities based on business and project needs.
• 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

• Recognized subject matter expertise 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 expert audiences and key opinion leaders.
• 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 management, surgeons, external experts, and other stakeholders.
• Demonstrated leadership, initiative, and accountability.

About US Tech Solutions:

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 www.ustechsolutions.com.

US 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:

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