Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Research Principal Engineer I
Work Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
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, 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.
Skills:
- Expected Areas of Competence (i.e., knowledge, skills and abilities)
- 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.
Education/Experience Requirements
- Master's degree in a relevant scientific discipline required; PhD or DVM preferred. Relevant disciplines may include neuroscience, biomedical science, biology, toxicology, materials science, or a related field.
- Bachelor's degree with significant directly relevant experience may be considered in lieu of an advanced degree.
- Typically requires: Master's degree with 5+ years of relevant industry experience, or PhD or DVM with 3+ years of relevant industry experience, or Bachelor's degree with 10+ years of relevant experience.
- 3-5 years of research experience in neuroscience, tissue histology, or related preclinical research areas.
- 3-5 years of hands-on experience in preclinical in vivo research, including large animal model testing.
- 5+ 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 required.
- Experience supporting regulated product development and cross-functional research programs is preferred.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $112.87 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Biologyunmatched
- Biomedicineunmatched
- Clinical Practices/Protocolsunmatched
- Communication Skillsunmatched
- Contract Research Organization (CRO)unmatched
- Cross-Functionalunmatched
- Diversityunmatched
- Functional Programming Languagesunmatched
- Histologyunmatched
- ISO (International Organization for Standardization)unmatched
- Laboratoryunmatched
- Leadershipunmatched
- Manufacturingunmatched
- Marketingunmatched
- Material Scienceunmatched
- Medical Equipmentunmatched
- Medical Recordsunmatched
- Negotiation Skillsunmatched
- Neuroscienceunmatched
- Orthopedicsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Engineeringunmatched
- Process Manufacturingunmatched
- Product Developmentunmatched
- Product Documentationunmatched
- Product Supportunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Research & Development (R&D)unmatched
- Research Protocolsunmatched
- Risk Analysisunmatched
- Salesunmatched
- Strategic Planningunmatched
- Support Documentationunmatched
- Team Playerunmatched
- Technical Presentationunmatched
- Technical Strategyunmatched
- Technical Writingunmatched
- Test Strategyunmatched
- Testingunmatched
- Time Managementunmatched
- Toxicologyunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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