Research Principal Engineer I
Fusion Life Sciences
Job ID: 37606640
Client: Zimmer Biomet
Location: Warsaw, IN
Work Arrangement: Onsite
Contract Duration: 12 Months
Pay Rate: $100 $115/hr on W2
Interview Process: Onsite
Visa: Any Visa
Candidate Preference: Preferably Local Candidates
Relocation: Accepted
Travel: Up to 20%
Submission Deadline: EOD
Openings: 3
References: Not Required Job Summary
Zimmer Biomet is seeking a Research Principal Engineer I to lead and support investigation and research activities for orthopedic products. This role will drive research planning, study execution support, outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives.
The Research Principal Engineer I will serve as a scientific subject matter expert and advisor to cross-functional teams, including R&D, Marketing, Sales, Clinical Affairs, and Regulatory Affairs.
The role will also act as a key scientific liaison with external key opinion leaders (KOLs), laboratories, suppliers, CROs, and partner organizations . The successful candidate will collaborate 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 .
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Lead or support the development, review, and approval of technical documentation, including:
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Study protocols
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Study reports
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Biological safety risk assessments
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Ensure biological safety documentation and evaluations are aligned with ISO 10993 requirements.
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Develop strategies for technical investigations and provide scientific expertise to research teams and cross-functional partners.
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Contribute biological safety content and supporting rationale for regulatory submissions and related technical documentation.
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Serve as a subject matter resource for biological evaluation activities related to new product development and sustaining products across the portfolio.
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Coordinate, initiate, and track laboratory studies and associated deliverables.
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Conduct biocompatibility assessments and organize required biological safety testing.
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Support the development of testing strategies and biological safety risk assessments for orthopedic products.
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Present scientific and technical information to internal groups, stakeholders, and regulatory bodies as necessary.
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Provide medical and scientific expertise to project teams, Marketing, Global Sales, and Medical Information functions as needed.
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Develop materials for project updates, technical reviews, and scientific/data presentations.
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Support relationships and scientific interactions with key opinion leaders and external collaborators .
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Contribute to additional neuro-related research activities based on business and project needs.
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Collaborate with cross-functional teams across R&D, design, process engineering, manufacturing, quality, regulatory, corporate, and site organizations.
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Support regulated product development and cross-functional research programs.
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Provide scientific guidance and technical leadership on complex research and biological safety matters.
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 Biological Safety & Regulatory Expertise-
Recognized subject matter expertise in biological safety and ISO 10993 .
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Strong understanding of orthopedic device manufacturing, quality, and regulatory requirements .
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Strong foundation of internal and external training in biological safety.
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Knowledge and experience with biological evaluation and biocompatibility assessment .
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Ability to develop and support biological safety risk assessments for medical devices.
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Understanding of regulated product development and associated regulatory requirements.
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Strong experience in preclinical and scientific research.
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Ability to present preclinical and scientific data clearly, credibly, and persuasively to expert audiences and key opinion leaders.
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Ability to communicate complex scientific concepts in a clear, concise, and audience-appropriate manner.
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Ability to develop scientific strategies for technical investigations.
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Ability to evaluate complex scientific and technical situations and identify practical solutions.
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Ability to expand current knowledge, methods, and procedures and establish approaches that others can build upon.
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Strong written, verbal, and presentation skills.
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Ability to respond confidently to scientific and regulatory questions.
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Ability to discuss complex topics with confidence and credibility.
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Ability to communicate sensitive or complex information effectively with:
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Management
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Surgeons
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External experts
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Key opinion leaders
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Cross-functional stakeholders
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Regulatory personnel
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Strong negotiation and collaboration skills related to scope, design, processes, and timelines .
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Ability to balance cross-functional priorities while meeting customer expectations and project timelines.
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Demonstrated professionalism and ability to represent the company effectively, including in challenging or conflicting situations.
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Strong and independent problem-solving capabilities.
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Effective use of resources, sound judgment, and strong execution skills.
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Demonstrated leadership, initiative, and accountability.
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Proven ability to manage multiple priorities and execute projects within established timelines.
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Strong project management capabilities.
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Master's degree in a relevant scientific discipline is required.
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A PhD or DVM is preferred .
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Relevant disciplines may include:
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Neuroscience
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Biomedical Science
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Biology
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Toxicology
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Materials Science
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Related scientific disciplines
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A Bachelor's degree with significant directly relevant experience may be considered in lieu of an advanced degree.
Candidates should typically meet one of the following experience/education combinations:
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Master's degree + 5+ years of relevant industry experience, OR
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PhD or DVM + 3+ years of relevant industry experience, OR
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Bachelor's degree + 10+ years of relevant experience.
Additionally:
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3 5 years of research experience in neuroscience, tissue histology, or related preclinical research areas.
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3 5 years of hands-on experience in preclinical in vivo research , including large animal model testing.
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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.
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Demonstrated experience with successful project management is required.
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Experience supporting regulated product development and cross-functional research programs is preferred.
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Biological safety
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ISO 10993
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Biological evaluation
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Biocompatibility assessment
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Biological safety risk assessment
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Medical device R&D
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Orthopedic medical devices
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Preclinical research
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In vivo research
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Large animal model testing
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Neuroscience research
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Tissue histology
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Scientific investigation
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Regulatory documentation
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Technical documentation
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Study protocols and reports
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Laboratory study coordination
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Research project management
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Cross-functional collaboration
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Scientific data presentation
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Orthopedic medical device development
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Medical device biological safety
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Preclinical in vivo studies
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Large animal models
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Neuroscience or neuro-related research
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Tissue histology
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CRO/laboratory management
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Key Opinion Leader (KOL) engagement
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Regulatory submissions
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ISO 10993 biological evaluation
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Experience working with R&D, Clinical Affairs, Quality, Regulatory Affairs, Manufacturing, and Design teams
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Travel required up to 20% .
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Position: Research Principal Engineer I
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Job ID: 37606640
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Client: Zimmer Biomet
-
Location: Warsaw, Indiana
-
Work Arrangement: Onsite
-
Contract: 12 Months
-
Pay Rate: $100 $115/hr on W2
-
Interview: Onsite
-
Visa: Any Visa
-
Relocation: Accepted
-
Local Candidates: Preferably local
-
Travel: Up to 20%
-
Openings: 3
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Submission Target: EOD
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References: Not Required
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