Manager, Performance and Functional Analysis

Kindeva Drug Delivery; Woodbury (MN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, & Vision Insurance

Health Savings Accounts

Flexible Spending Accounts

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

401k Benefits

Job summary

An established industry player is seeking a Technical Expert Manager for Biomedical Devices to provide advanced technical expertise and leadership in testing. This role involves collaborating with internal and external clients, overseeing compliance in a cGMP laboratory, and ensuring the highest standards in performance and functional testing. The ideal candidate will have extensive experience with ISO standards and testing methodologies, along with strong leadership skills. Join a mission-driven team dedicated to improving health outcomes and making a significant impact in the biomedical field.

Qualifications

• 5+ years in performance and functional method development in a cGMP/ISO 17025 lab.
• Expertise in ISO 11040, 11608 and USP <381> functionality testing.

Responsibilities

• Lead performance and functional testing of combination products.
• Oversee testing in a cGMP laboratory ensuring compliance with guidelines.

Skills

Troubleshooting

Organizational Skills

Communication Skills

Attention to Detail

Flexibility

Team Collaboration

Education

Bachelor’s degree in Science or Engineering

Bachelor’s degree in Device or Mechanical Engineering

Tools

Instron Universal Testing Systems

Electronic Laboratory Notebooks

LIMS

CAD programs

Job description

Technical Expert Manager – Biomedical Device

11200 Hudson Rd, Woodbury, MN 55129, USA

Job Description

Posted Wednesday, March 19, 2025 at 5:00 AM

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 Technical Expert 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 <381> 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 <381> 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 <381> 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.

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).

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.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!