Performance and Functional Analysis Manager – Biomedical Device - #1397699

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The position as a Performance and Functional Analysis Manager – Biomedical Device will provide advanced technical expertise and leadership in performance and functional testing of combination products. This individual will work closely with both internal and external clients to define testing needs and oversee execution of testing.

Job Responsibilities

Represent Kindeva externally as subject matter expert on performance and functional testing through publications, presentations, industry working groups and other means.

Provide advanced technical support for the qualification, validation, and troubleshooting of equipment and methodology for ISO 11040, 11608, USP functionality testing and other relevant standards.

Provide support for the development, validation, and troubleshooting of testing equipment and processes.

Oversee, plan and execute testing within an analytical laboratory operating under cGMP conditions, ensuring compliance with all relevant guidelines.

Operate and maintain Instron Universal Testing Systems and other analytical instrumentation for mechanical testing, ensuring accurate and reliable results.

Prepare detailed reports, validation protocols, and technical documentation for both internal and external clients.

Maintain awareness of industry trends to identify threats and opportunities to Kindeva.

Assist in implementing testing solutions in collaboration with internal and external customers.

Responsible for hiring and training of analysts and lab technicians.

Basic Qualifications

Bachelor’s degree or higher in a Science, Engineering or a related discipline.

Minimum 5 years’ experience in performance and functional method development in a cGMP/ISO 17025 laboratory, with strong knowledge of ISO 11040, 11608 and USP functionality testing requirements.

Demonstrated expertise operating Instron Universal Testing Systems and similar equipment for medical device and functional testing.

Preferred Qualifications

Bachelor’s degree or higher in Device or Mechanical Engineering

8+ years’ experience in medical device method development and testing in a cGMP/ISO 17025 laboratory, with strong knowledge of ISO 11040, 11608 and USP functionality testing requirements.

Experience working with Electronic Laboratory Notebooks and LIMS.

Experience in equipment qualification, process design, and compliance testing.

Proven experience with regulatory requirements and standards for medical devices, including design controls and validation protocols.

Proficiency in CAD programs.

Past supervisory or leadership experience.

Skills

• Demonstrated ability to troubleshoot complex technical challenges and provide effective solutions.
• Strong organizational and multi-tasking skills
• Excellent communications and interpersonal skills
• High attention to detail in developing and executing protocols, test methods, and associated documentation.
• Flexibility and adaptability to changing project requirements and timelines.
• Ability to work with cross-functional teams and external stakeholders to achieve project goals.
• Ability to act quickly and decisively.
  
  

California residents should review our Notice for California Employees and Applicants before applying.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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