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 specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in a laboratory, manufacturing and office environment.
• Personal protective equipment may be required as dictated by work environment.

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Salary Range: minimum of $140,000 to a maximum of $183000

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Healthmark, A Getinge company was founded in 1969 and employs over 300 people and is a growing company. We strive to provide customers with quality products and support services in a timely and effective manner.   At Healthmark a Getinge company, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life InsuranceShort and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement.

Salary Range for this position is a minimum of $122,400 to a maximum of $183,600 

Healthmark a Getinge company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.