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Biocompatibility Engineer Jobs in Utah (NOW HIRING)

Biocompatibility Engineer information

What is the difference between Biocompatibility Engineer vs Materials Scientist?

AspectBiocompatibility EngineerMaterials Scientist
Required CredentialsBachelor's or Master's in biomedical engineering, biology, or related fields; certifications in biocompatibility testingBachelor's or Master's in materials science, chemistry, or engineering; advanced degrees often preferred
Work EnvironmentMedical device companies, research labs, regulatory agenciesResearch institutions, manufacturing, aerospace, automotive industries
Industry UsageDesign and testing of biocompatible medical devices and implantsDevelopment of new materials for various applications, including medical, industrial, and consumer products

While both roles involve materials and testing, a Biocompatibility Engineer specializes in ensuring materials are safe for medical use, focusing on biological interactions. A Materials Scientist has a broader scope, working on developing and analyzing materials across multiple industries. The two roles often collaborate but serve distinct functions within product development and safety assurance.

What does a Biocompatibility Engineer do?

A Biocompatibility Engineer is responsible for evaluating and ensuring that materials and devices intended for medical use are safe and compatible with biological systems. Their work involves assessing the interactions between medical devices and human tissues to prevent adverse reactions. They conduct laboratory tests, analyze data, and prepare technical documentation to meet regulatory standards. Biocompatibility Engineers play a crucial role in the development and approval of medical devices, working closely with regulatory agencies and product development teams.

What are the key skills and qualifications needed to thrive as a Biocompatibility Engineer, and why are they important?

To thrive as a Biocompatibility Engineer, you need a strong background in biomedical engineering or life sciences, with expertise in toxicology, materials science, and regulatory standards such as ISO 10993. Familiarity with laboratory testing protocols, risk assessment tools, and regulatory submission systems is typically required, and certifications like Certified Biological Safety Professional (CBSP) can be advantageous. Strong analytical thinking, meticulous attention to detail, and effective communication skills help in interpreting data, preparing reports, and collaborating with cross-functional teams. These competencies are crucial for ensuring medical devices are safe for human use and meet global compliance requirements.

What are some common challenges faced by Biocompatibility Engineers during the device development process?

Biocompatibility Engineers often encounter challenges in selecting appropriate materials that meet regulatory standards and ensuring compatibility with biological systems. They must navigate complex testing protocols and documentation requirements to demonstrate safety and effectiveness, which can be time-consuming and require cross-functional collaboration with regulatory, quality, and R&D teams. Additionally, staying updated with evolving international regulations and standards is vital, as non-compliance can delay product approvals and market entry.
R&D Engineer (Coatings)

R&D Engineer (Coatings)

SCIENTIA VASCULAR INC

West Valley City, UT • On-site

$95K - $105K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago


Job description

About Scientia Vascular:

Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.

Position Summary:

Responsible for the research, design, development, and optimization of hydrophilic coating systems for medical devices. This role will lead and contribute to cross-functional development teams supporting coating formulation, surface preparation, application processes, scale-up, and verification/validation activities. The position will work with general direction and exercise significant technical judgment in solving complex materials, process, and performance challenges related to hydrophilic coatings.

Primary Responsibilities:

  • Lead and support R&D for hydrophilic coatings on medical devices, including new product development and lifecycle improvements
  • Design, develop, and optimize coating formulations, surface treatments, and application processes (dip, spray, UV/thermal cure)
  • Evaluate coating performance (lubricity, durability, adhesion, thickness, uniformity, aging, biocompatibility) using bench and in-vitro testing
  • Plan and execute research investigations, including bench and animal studies, to support coating performance and clinical use
  • Select, characterize, and qualify substrates, primers, polymers, solvents, and additives compatible with hydrophilic coating systems
  • Develop, validate, and maintain test methods for coating characterization and performance
  • Design and execute process development, scale-up, and manufacturing transfer studies
  • Build prototypes and coated components; translate early concepts into robust, manufacturable processes
  • Troubleshoot coating, material, and process issues related to defects, variability, or field performance
  • Plan and coordinate verification and validation (V&V) testing; author technical reports supporting regulatory submissions
  • Generate and maintain design control documentation, specifications, protocols, and reports in compliance with FDA and international regulations
  • Contribute to intellectual property through invention disclosures related to coating chemistry, processes, or applications
  • Design or specify coating and test tooling, fixtures, and equipment
  • Maintain accurate laboratory notebooks documenting experiments, formulations, processes, and results
  • Collaborate with process development, manufacturing, quality, regulatory, clinical, and marketing teams to support commercialization
  • Provide technical support for fielded products, including complaint investigations and case support
  • Train and mentor technicians or junior engineers as needed
  • Perform other duties as assigned, with or without accommodation

Requirements:

  • BS in Engineering, Materials Science, Chemistry, Chemical Engineering, or related field
  • Minimum of 4 years of medical device R&D experience, including hydrophilic or lubricious coatings
  • Proven track record of developing and launching coated medical devices into production
  • Strong knowledge of polymer chemistry, surface science, and coating adhesion mechanisms
  • Hands-on experience with coating application, curing, and process optimization
  • Experience with medical device design controls and regulatory requirements (FDA, ISO)
  • Demonstrated ability to develop and validate test methods and statistically analyze data
  • Experience supporting scale-up, technology transfer, and manufacturing readiness
  • Familiarity with biocompatibility requirements for coated devices
  • Strong written and verbal communication skills
  • Proficient in Microsoft Excel and Word for data analysis and reporting

Key benefits we provide:

  • Medical, Dental, Vision insurance
  • Generous Paid Time Off (PTO)
  • Paid Parental Leave
  • Paid Holidays
  • 401k Plan (with a generous employer match)
  • Life Insurance (company paid)
  • Short-Term & Long-Term Disability Insurance (company paid)
  • Subscription to Calmhealth.com
  • Employee Assistance Program
  • An environment of belonging where everyone can thrive

Commitment to Equal Opportunity:

The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds.

Visit our website and learn more about us at www.scientiavascular.com