IL
Research Principal Engineer I
ICONMA, LLC
- 🇺🇸 United States
- Remote
- Staff / Principal
- 9 hours ago
- $108.91 – $112.93 / hour
9 hours ago
Â
Responsibilities:
- Identify, assess, and support the remediation of 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 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.
- This is not intended to be an exhaustive list of duties and may not include all essential functions of the role.
Requirements:
- 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, 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 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.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Research Principal Engineer I · ICONMA, LLC