Biocompatibility Evaluation Analyst

2 weeks ago

Rancho Santa Margarita, California, United States Applied Medical Full time

_________________________________________________________________________________:

Applied Medical is a pioneering medical device organization with a robust business framework and a strong commitment to innovation, driven by swift growth and expansion. With over 35 years of experience in developing and manufacturing cutting-edge surgical technologies, our company has established a solid reputation for excellence in the healthcare sector. Our distinctive business model, paired with our dedication to delivering top-quality products, allows team members to contribute significantly beyond the typical scope of their roles.

Position Overview:
As a member of the Biological Sciences department at Applied Medical, you will play a crucial role in transforming medical device manufacturing. This position involves working onsite at our global headquarters to coordinate and assess various biological testing methods that support our production teams. You will collaborate with multiple groups within Applied Medical, consistently striving to meet or exceed customer expectations through our unwavering commitment to exceptional quality.

Key Responsibilities:

  • Data Analysis: You will analyze data and interpret results, identifying significant trends and patterns that are essential for determining product biocompatibility.
  • Detail Orientation: Your attention to detail will ensure adherence to protocols and procedures, validating results and identifying potential issues through thorough review of methodologies.
  • Documentation and Reporting: You will prepare and review comprehensive reports that document product evaluations, testing procedures, results, and conclusions, which are vital for regulatory submissions and internal decision-making.
  • Process Improvement: You will identify opportunities for enhancing biocompatibility evaluation and testing processes, contributing to the establishment of best practices within the organization.
  • Risk Management: You will provide expertise on biocompatibility aspects and engage in risk assessments related to biological safety.

Performance Objectives:

Within your initial 30 days:

  • Complete all foundational training courses with a passing grade of 95% or higher, demonstrating swift integration into company processes.
  • Finish all internal training related to the biological evaluation process and necessary documentation.
  • Engage in team meetings and operational discussions.

Within 60 days:

  • Demonstrate a strong technical understanding of the biological evaluation process.
  • Support team meetings and agendas effectively.
  • Take ownership of one or more projects requiring minimal guidance.
  • Exhibit leadership and initiative in managing low to moderately-guided projects.

Within 90 days to one year:

  • Build interpersonal relationships to effectively achieve project objectives and deliverables.
  • Become a subject matter expert in biocompatibility, leading complex projects with minimal oversight.
  • Review and approve biocompatibility documentation as a representative of the Biological Sciences Department.
  • Demonstrate a comprehensive understanding of Applied's Quality Management System and troubleshoot challenges affecting project timelines.
  • Manage a variety of projects independently.

Position Requirements:

  • Bachelor's Degree in a relevant scientific discipline.
  • A minimum of two years of experience in a related industry, with a preference for medical device experience.
  • Familiarity with biocompatibility evaluation, testing, and ISO 10993 standards.
  • Ability to work both independently and collaboratively within a team.
  • A positive attitude and openness to constructive change.
  • Customer service orientation.
  • Capacity to manage multiple tasks and prioritize projects in alignment with departmental and organizational goals.
  • Detail-oriented, organized, and capable of managing testing projects in a dynamic environment.
  • Strong writing, verbal, and interpersonal communication skills.
  • Proficiency with computers, including Microsoft Office Suite, Adobe Acrobat, and general office equipment.

If you are passionate about making a meaningful impact, driving innovation, and contributing to a dynamic team, we invite you to explore an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to make a significant impact, unlike conventional roles.

Benefits:

  • Competitive compensation range: $75,000 per year (California).
  • Comprehensive benefits package.
  • Training and mentorship opportunities.
  • On-campus wellness activities.
  • Education reimbursement program.
  • 401(k) program with discretionary employer match.
  • Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

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