Senior Manager, Performance Testing & Clinical Evaluations - Miami, FL | Biospace
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Senior Manager, Performance Testing & Clinical Evaluations

Beckman Coulter, Inc.

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Location:
Miami, FL
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
BEC007027
Salary:
Commensurate w/ exp
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The senior manager of the Performance Testing and Clinical Evaluations provides strategic direction and leads the development and execution of system performance testing, including clinical studies, through the entire product life cycle.  Such studies include system performance testing in various prototype phases, product design verification and validation studies, clinical studies in support of regulatory submissions, benchmarking studies against competitive production offerings, product evaluations and any other studies or special assignments.

Job Responsibilities
Provides verification and validation (V&V), and clinical expertise to the research and development teams in the field of urinalysis.
Collaborates in the conceptualization of novel products considering the clinical utility and/or health economics requirement of our targeted customers.
Leads various V&V and clinical studies, as well as performance testing of prototype units for the next generation urinalysis systems.
Applies sound bio-statistical principles; designs and conducts meaningful clinical and/or analytical experiments; reviews and interprets experimental data in support of statistically significant conclusions and summarizes such conclusions for the research and development teams and management.
Staff management: oversees the day-to-day function of the Performance Testing and Clinical Evaluations Laboratory, including execution according to project priorities, adequate data acquisition, GLP’s, data reduction and cogent technical reports.  Evaluates staff proficiency, manages performance and provides training.
Enforces Good Laboratory Practices ensuring data integrity, adequate specimen/sample traceability and preservation, adequate selection, certification, validation and maintenance of commercial testing apparatus (or Beckman Coulter designed equipment) as required to ensure exceptional quality of laboratory services.  Implements quality control and quality assurance procedures compliant with FAQ-QSR’s, ISO and other regulatory guidelines or protocols applicable to the product under evaluation.  Expeditious documentation of corrective and preventive actions is a must.
Serves as an integral part of new product development. Collaborates with R&D engineering teams in evaluating the system performance at various prototype phases.
Development and/or selection of clinical reference methods in collaboration with other members of the R&D staff.  In absence of commercially available reference methods, the Manager of Clinical Evaluations will select (or design) and implement “esoteric” or “home-brew” clinical laboratory assays for design verification or experimental purposes only.  The selection of such assays or scientific methodologies will be subject to strict scientific scrutiny and should be supported by robust scientific and statistical analyses to ensure acceptance by internal and external scientists, as well as regulatory bodies.
Interfaces with key opinion leaders, physicians, customers, regulatory and marketing personnel during the conceptualization, execution and interpretation of study results.
Trains laboratory personnel and/or peers in formulation/application processes, procedures and analysis techniques to ensure the personnel understanding the fundamental principles, techniques and the expectations in the results.
Writes, amends, reviews, and implements SOPs for the Clinical Studies laboratory to ensure compliance with regulatory policies and Beckman’s SOPs.
Ensures all measuring devices being utilized are functioning properly, well maintained and within their stated calibration dates.
Maintains professional expertise through literature, courses, seminars and training to ensure expertise is kept current.
Represents Beckman Coulter in scientific and clinical forums, as required.
Develops solid understanding of Danaher Business System tools and applies to day-to-day work.
Ensures compliance to organizational policies, procedures and regulatory requirements.

Requirements

Bachelor degree in Chemistry, Biochemistry, Medical Technology or related field with no less than 14+ years of experience, or Master’s/PhD degree with 12+ in a medical device or IVD industry.
Related experience includes no less than 6+ years of prior experience leading a R&D testing or clinical team in a management role. Prior management experience in GLP labs and/or hospital/clinical labs a plus.
Prior working experience in one of the following fields: Urinalysis, Body Fluids, Hematology or Flow Cytometry – highly desirable.
Clinical Chemistry Board Certification from American Association of Clinical Chemistry (AACC) - desirable.
Competent in the utilization of SAS, JMP, or other statistical analysis software. Deep understanding of bio-statistics.
At least six years IVD industry experience. Familiarity of clinical trials for Class II IVD products 510(k) a plus.
Ability to present complex clinical problems in terms understandable by engineers and other non-clinical members of the product development teams.
Excellent protocol writing and experimental conceptualization skills.
Must be a self-starter with the ability to work in a highly independent, multi-tasking and self-directed work environment.
Ability to perform in both a team environment and as an individual.
Strong theoretical and applied knowledge of clinical laboratory methods/applications and development, validation and stability testing.
Knowledge and experience with Good Laboratory Practices (GLP),    Good Clinical Practices (GCP), Medical Device (class II) and FDA submission.
Demonstrated experience with objective setting, performance evaluations, compensation, coaching and mentoring is highly desirable.
Superior organizational, project planning and documentation skills.
Knowledge and experience with ICH/CLSI guidelines and standards especially as applied to analytical method validation.
Must be proficient in all MS Office programs.
Proven track of record in launching products and delivering key milestones.
Familiarity of entire product development cycle is a must.
Proven ability to develop a culture of teamwork and willingness to roll up their sleeves to get the job done.
Multidisciplinary experience overseeing Development and Program/Project Management.
History of driving project execution and timely delivery while ensuring a quality focus.
Ability to work well with people and be both highly motivated and motivating.
Ability to make difficult decisions based on the business needs.
Ability to work in a fast-paced, and often ambiguous environment where continuous improvement is a way of life.
Excellent communication skills. Ability to interface with various internal and external stakeholders. Ability to present milestones and stage gates to senior executives.
Experience in medical device design & development a plus.
Ability to travel as needed.
This is a great opportunity of being part of a highly committed & engaged team. You can take pride in the fact that you are giving back to society by working on instruments that help save lives and keep us healthy.

Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.