Manager, R&D Testing

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Function Summary:

Responsible for scientific and technical leadership, personnel development and management, and directing daily activities of R&D laboratory group.

 

Job Functions: (Primary “essential” duties and responsibilities)

• Responsible for overseeing all R&D protocol generation, test execution, and protocol event reporting with the R&D organization
• Lead Design Verification / Design Validation planning, execution, interpretation, and reporting
• Designs, conducts, and interprets experiments to support Healthmark consumable product development, evaluation, and verification
• Apply scientific and technical test acumen toward the development of new test methodologies and improvement of existing methodologies, as well execution of test method validations
• Provide technical oversight and leadership on matters regarding device testing for all product groups to include R&D and Sustaining Engineering, Quality, Manufacturing/Production, and Regulatory
• Identify areas of improvement for test methods by staying current with best practices.
• Coach and mentor laboratory personnel.
• Coordinate and run project meetings as needed.
• Lead special projects as needed. 
• Contributes to team effort by accomplishing related duties as requested.
• Develop budget and justification for new equipment and upgrades to existing equipment.
• Design and execute equipment qualification plans
• Develop test strategies with R&D Engineering and apply test group resources necessary for completion of assigned tasks and/or projects.
• Ensure laboratory compliance with current Good Laboratory Practices
• Manages external labs to form study plans, execute the studies, and analyze the results.
• Maintains compliance with current good documentation practices.
• Defining and implementing the role design verification/validation testing, as well as formative and investigative testing, plays within the organizational structure.
• Deploying and managing the appropriate testing framework to meet testing mandates.
• Implementing and evolving appropriate measurements and metrics for laboratory and personnel performance.
• Planning, deploying, and managing the testing effort for any given request.
• Managing and growing laboratory assets (personnel, equipment, tools, process) based upon organization objectivesRepresent organization and participate in relevant standards (e.g., AAMI, ASTM) development

Required Knowledge, Skills and Abilities: Soft skills and technical requirements to be listed here.

• Must be detail-oriented and have the ability to troubleshoot, investigate, and address protocol events
• Demonstrated personnel management, project management and lab management experience. 
• Direct experience in medical device industry is required.
• Strong computer skills including MS Office (Excel, Word) applications are required.

 

Minimum Requirements:minimum requirements for the position.

• Masters or Ph.D. in a relevant Scientific or Engineering Field
• A minimum of 8 years progressive experience with test methods and test method validations plus 5 years managing a group of scientists, engineers and/or technicians.
• A minimum of 5 years working in a medical device and/or pharmaceutical laboratory testing to support regulated products

Quality Requirements (Required language- Please do not edit):

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the