Biocompatibility Reporting Analyst

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Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field.  Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

Join Applied Medical and be at the forefront of revolutionizing medical device manufacturing. As part of our Biological Sciences department, you will be working onsite at our global headquarters coordinating and reviewing various types of biological testing in support of our production teams. This involves collaborating and servicing many different groups within Applied Medical as well as striving to consistently meet or exceed our customer expectations through our continual commitment to exceptional work quality.  

Key Responsibilities: 

• Analytical Skills: You should be able to analyze data and interpret results, identifying trends and patterns that may be important in determining the biocompatibility of a product.  

• Attention to Detail: Attention to detail skills ensure that you follow protocols and procedures accurately to ensure the validity of the results. You will also need to be able to identify the source of problems by reviewing your procedures and methodology, which can lead to insights for improvement or adjustments. 

• Documentation and Reporting: Prepare and review detailed reports documenting product evaluation, testing procedures, results, and conclusions. These reports are crucial for regulatory submissions and internal decision-making processes. 

• Continuous Improvement: Identify opportunities for process improvement within biocompatibility evaluation & testing procedures and contribute to the development of best practices within the organization.  

• Risk Management: Contribute to risk management processes by providing expertise on biocompatibility aspects and participating in risk assessments related to biological safety. 

Performance Objectives: 

Within your first 30 days: 

• Complete all Applied Learning foundational courses with a passing grade of 95% or above, demonstrating rapid integration into company processes. 
• Complete all internal team trainings related to the biological evaluation process and accompanying documentation.   
• Participate in team meetings and operations.

Within 60 days:

• Exhibit a strong technical understanding of the biological evaluation process.   
• Support team meetings and agendas.   
• Take on one or more projects that require low to moderate guidance.   
• Take ownership of low to moderately-guided projects, demonstrating leadership and initiative.  

Within 90 days to one year:

• Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables.   
• Become a subject matter expert in biocompatibility, leading moderate to complex projects with minimal guidance or direction.   
• Be able to review and approve biocompatibility documentation as a representative of the Biological Sciences Department. 
• Demonstrate a strong understanding of Applied’s Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines.    
• Handle a variety of projects on your own.  

Position Requirements

• Doctorate (PhD) in a relevant scientific field, or Master’s degree in a relevant scientific field with a minimum of three years of industry experience.
• Experience with Biocompatibility evaluation, testing and ISO 10993 standards. 

• Ability to work independently and as part of a team.
• Positive attitude and embraces constructive change. 
• Customer service oriented.
• Ability to multi-task and prioritize projects to align with department and organizational objectives.
• Detail oriented, organized, and able to manage testing projects in a fast-paced environment.  
• Effective writing, verbal, and interpersonal communication skills.
• Must be familiar with computers including Microsoft Office Suite, Adobe Acrobat, copiers and general office equipment.  

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles. 

Preferred

• Experience with medical devices. 

Benefits

• Competitive compensation range: $75000 - $95000 / 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.

Salary : $75,000 - $95,000