Significant experience in biocompatibility assessment within a medical device environment ... MS or PhD in a related field with 5+ years of relevant experience * Relevant fields include:
Significant experience in biocompatibility assessment within a medical device environment ... MS or PhD in a related field with 5+ years of relevant experience * Relevant fields include:
MD, PharmD, PhD, PA or RN with clinical experience preferred. * 3-5 years of field based MSL experience and/or 3-5 years of work experience in the medical device or pharmaceutical industry required.
MD, PharmD, PhD, PA or RN with clinical experience preferred. * 3-5 years of field based MSL experience and/or 3-5 years of work experience in the medical device or pharmaceutical industry required.
MD, PharmD, PhD, PA or RN with clinical experience preferred. * 3-5 years of field based MSL experience and/or 3-5 years of work experience in the medical device or pharmaceutical industry required.
MD, PharmD, PhD, PA or RN with clinical experience preferred. * 3-5 years of field based MSL experience and/or 3-5 years of work experience in the medical device or pharmaceutical industry required.
Other Hourly Worker - Biomechanics
Omaha, NE · On-site
$15/hr
... medical device evaluation * Support data processing, documentation, and reporting Work Schedule ... PhD in Biomechanics or related field * Strong coding skills in C, C#, or Python * Background in ...
Other Hourly Worker - Biomechanics
Omaha, NE · On-site
$15/hr
... medical device evaluation * Support data processing, documentation, and reporting Work Schedule ... PhD in Biomechanics or related field * Strong coding skills in C, C#, or Python * Background in ...
... medical device evaluation * Support data processing, documentation, and reporting Work Schedule ... PhD in Biomechanics or related field * Strong coding skills in C, C#, or Python * Background in ...
... medical device evaluation * Support data processing, documentation, and reporting Work Schedule ... PhD in Biomechanics or related field * Strong coding skills in C, C#, or Python * Background in ...
Medical Device Phd information
What is a Medical Device PhD?
A Medical Device PhD is an individual who has earned a Doctorate (PhD) with a focus on medical devices, typically through research in biomedical engineering, materials science, or a related field. These professionals are experts in designing, developing, and testing medical technologies used for diagnosis, treatment, or monitoring of health conditions. They may work in academic research, the medical device industry, regulatory agencies, or clinical settings, contributing to the innovation and safety of medical products. Their work often involves multidisciplinary collaboration and advanced knowledge of engineering, biology, and regulatory standards.
What are the key skills and qualifications needed to thrive as a Medical Device PhD, and why are they important?
To thrive as a Medical Device PhD, you need a doctoral degree in biomedical engineering or a related field, with expertise in medical device design, development, and regulatory standards. Familiarity with technical tools such as CAD software, statistical analysis programs, and knowledge of FDA or CE regulatory processes is crucial. Strong problem-solving, communication, and project management skills set top candidates apart in multidisciplinary teams. These skills enable the successful creation, testing, and approval of innovative medical devices that meet safety and efficacy standards.
What are some common challenges faced by PhDs working in the medical device industry, and how can they be addressed?
PhDs entering the medical device industry often encounter challenges such as adapting to the fast-paced product development cycle, working within regulatory frameworks, and translating academic research into practical solutions. Success in this role requires strong communication skills to collaborate with cross-functional teams like engineering, marketing, and regulatory affairs. Building familiarity with industry standards (e.g., ISO 13485, FDA regulations) and gaining hands-on experience with project management can help address these challenges and ensure a smooth transition from academia to industry.
What is the difference between Medical Device Phd vs Medical Device Engineer?
| Aspect | Medical Device Phd | Medical Device Engineer |
|---|---|---|
| Required Credentials | PhD in relevant field, research experience | Bachelor's or Master's in engineering or related field |
| Work Environment | Research labs, development teams, academia | Design, testing, manufacturing settings |
| Employer & Industry Usage | Universities, research institutions, R&D departments | Medical device companies, manufacturing firms |
| Common Search & Comparison | Yes | Yes |
The Medical Device Phd typically focuses on research, development, and innovation in medical devices, often working in labs or academia. In contrast, Medical Device Engineers are more involved in designing, testing, and manufacturing medical devices in industry settings. Both roles require technical knowledge, but their daily tasks and work environments differ significantly.
What can I do with a medical device PhD?
A medical device PhD prepares individuals for research, development, and regulatory roles in the medical device industry. Graduates can work in product design, clinical evaluation, quality assurance, or regulatory affairs, often utilizing skills in biomedical engineering, data analysis, and medical sciences. These roles are typically found in healthcare companies, research institutions, or regulatory agencies.
What are popular job titles related to Medical Device Phd jobs in Nebraska?
For Medical Device Phd jobs in Nebraska, the most frequently searched job titles are:
What job categories do people searching Medical Device Phd jobs in Nebraska look for?
The top searched job categories for Medical Device Phd jobs in Nebraska are:
What cities in Nebraska are hiring for Medical Device Phd jobs?
Cities in Nebraska with the most Medical Device Phd job openings:
Full-time
Re-posted 3 days ago
Job description
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Sr. Expert Biocompatibility Consultant
The Sr. Expert Biocompatibility Consultant is a senior scientific contributor responsible for leading biocompatibility assessments and biological evaluations for medical device products in global, highly regulated environments. This role operates at the assessment, strategy, and advisory level and is ideal for professionals who have already built depth in biocompatibility and now influence decisions through technical judgment, documentation, and communication. You will partner closely with clients, internal technical teams, and leadership to develop defensible, regulator-ready assessments that safeguard patient health and support product approval worldwide.
Key Responsibilities
Biocompatibility & Scientific Leadership
Lead development and authorship of biocompatibility assessments, biological evaluations, and risk assessments
Perform and synthesize literature-based evaluations of materials, compounds, and device use
Apply ISO 10993 principles and FDA expectations to support regulatory submissions and decision-making
Provide peer review and technical guidance on complex or high-risk projects
Author opinion memos and other patient safety-focused technical documentation
Client & Consulting Engagement
Serve as a subject-matter expert during client discussions and project initiation
Clearly communicate scientific and regulatory rationale to technical teams, clients, and senior stakeholders
Collaborate cross-functionally to deliver integrated, high-quality project outcomes
Support proposal development and scope review in partnership with project leadership
Thought Leadership & Standards
Participate in international standards development
Deliver technical presentations at conferences, seminars, webinars, and industry forums
Contribute to continuous improvement of internal processes, templates, and best practices
Required Qualifications (Must-Have)
Significant experience in biocompatibility assessment within a medical device environment
Demonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documents
Strong working knowledge of FDA-regulated environments and applicable standards (ISO 10993)
Exceptional technical writing and verbal communication skills, including comfort presenting to senior and executive audiences
Proven ability to independently own projects and operate as a trusted expert
This role is not intended for early-career professionals or hands-on testing-focused profiles.
Highly Desired
Ability to bridge Biocompatibility and Medical Toxicology (biocompatibility expertise is primary)
Experience engaging with or supporting interactions with regulatory agencies
Interest in external-facing work, standards involvement, and scientific thought leadership
Education & Experience
Bachelor's degree in a relevant scientific discipline with 7+ years of relevant experience
ORMS or PhD in a related field with 5+ years of relevant experience
Relevant fields include: Biology, Chemistry, Toxicology, Biomedical Engineering, Materials Science, Biotechnology, Pharmacology, or Engineering.
Additional Information
Work Arrangement: Fully remote (onsite presence as needed based on location)
Travel: Approximately 20%, including occasional international travel
The Expert Biocompatibility Consultant will develop the initial draft of related projects to safeguard global health. This will include obtaining all necessary information from the client and performing the necessary literature research. This information will then be summarized in a technical format for the project and submitted for peer review. The Expert Biocompatibility Consultant will also assist with peer review as needed. The Expert Biocompatibility Consultant will participate in development of international standards, and will provide technical presentations at conferences and seminars.
Education and experience requirements:
Bachelor's degree in relevant science with 7 years' relevant experience or an MS/PhD degree
in related emphasis with 5 years' relevant experience.
Strong understanding and ability to apply biological evaluation principles preferred.
Consulting
Serve as primary writer on documents
Peer review team documents
Join calls as expert to support initial client discussions
Review quotes with project manager and team manager
Prepare templates and write risk assessments
Work cross-functionally with other departments on projects where collaboration is needed
Communicate with the client to obtain additional information for projects or related testing
Perform literature research on materials and compounds
Build and implement process improvements
Know and follow the Nelson service standard
Review and write assessments and other related documents as needed (i.e. Opinion Memos
for patient safety)
Regulatory Compliance
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
Know and follow company policies and procedures.
Complete required training on time.
Competencies of this position
Good project management skills
Owning projects with customers
Taking on STAT projects
Excellent communication skills
Leading phone calls
Excellent technical writing skills and expertise
Write regulatory responses with guidance
Attention to detail
Able to handle simple to moderately difficult assignments
Time management - must be able to respond to voicemails, emails, and other
communications in a timely manner
Able to multi-task and be self-motivated
Knowledge Microsoft Office applications (Word, Excel, PowerPoint, Outlook, etc.)
Work Authorization: This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States at the time of hire and must be able to maintain work authorization without current or future visa sponsorship.
Sotera Health goes to market through its three best-in-class businesses - Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
About Sotera Health
Sourced by ZipRecruiter
Industry
Health care and social assistance
Company size
1,001 - 5,000 Employees
Headquarters location
Broadview Heights, OH, US
Year founded
2017