Senior Biocompatibility Engineer

TekWissen ®; Englewood (CO); Teletrabalho; USD 85 000 - 90 000; Tempo integral

Resumo da oferta

TekWissen is seeking a Senior Biocompatibility Engineer in Englewood, CO for a 12-month temporary assignment with remote work options. The role focuses on supporting investigation and research for orthopedic products, including biocompatibility, safety risk assessments, and regulatory objectives.

You will collaborate across design, process engineering, manufacturing, quality, regulatory, and sites. The ideal candidate has a strong foundation in ISO 10993, orthopedic device manufacturing, and

Qualificações

• Bachelor’s degree in a relevant scientific discipline required; Master’s preferred.
• Typically requires Master’s with 3+ years of relevant industry experience, or Bachelor’s with 5+ years.
• 3+ years in medical device R&D with biological safety risk assessment.

Responsabilidades

• Identify, assess, and support remediation of existing orthopedic products.
• Develop, review, and approve technical documentation including study protocols and biological safety risk assessments per ISO 10993.
• Conduct biocompatibility assessments and organize required testing.
• Present scientific data to internal groups and stakeholders.

Conhecimentos

Biological safety (ISO 10993)

Orthopedic device knowledge

Regulatory knowledge

Scientific communication

Cross-functional collaboration

Formação académica

Bachelor's degree in biomedical sciences or related field

Master's degree preferred

Descrição da oferta de emprego

Job Title: Senior Biocompatibility Engineer

Location: Englewood, CO

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Remote

Pay Rate: $ 62.87 - $ 62.87/Hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.

Job Description:

Job Summary

Responsible for supporting investigation and research activities for orthopedic products. This role supports research planning, study execution support, and outcome tracking, biological evaluation, and risk assessment documentation to support product remediation and regulatory objectives. Collaborates across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to support broader project needs.

Principal Duties and Responsibilities:

• Identify, assess, and support the remediation of existing orthopedic products
• Support development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
• Contribute biological safety content and supporting rationale technical documents.
• 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 and stakeholders, as necessary.
• Develop materials for project updates, technical reviews, and data presentations.
• 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 (i.e., knowledge, skills and abilities)

• Strong foundation 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 stakeholders.
• 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 stakeholders.
• Demonstrated leadership, initiative, and accountability.

Education/Experience Requirements

• Bachelor’s degree in a relevant scientific discipline required; Master’s preferred.
• Relevant disciplines may include, biomedical science, biology, toxicology, materials science, or a related field.
• Typically requires: Master’s degree with 3+ years of relevant industry experience,
• or Bachelor’s degree with 5+ years of relevant experience.
• 3+ 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 preferred.
• Experience supporting regulated product development and cross-functional research programs is preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.