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. Strong and independent problem-solving skills, including the ability to evaluate complex situations, identify practical solutions, and execute effectively in a timely manner.
Numbers & Facts
Location
Englewood, CO
Description
Our Client, a Medical Devices/Healthcare company, is looking for a Research Principal Engineer I for their Englewood, CO/ Denver , CO/Remote location.
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.