PURPOSE AND SCOPE:
Oversees and controls the general conduct of biocompatibility tests by CROs. Leads and guides the teams activities in work processes ensuring compliance to regulatory requirements, quality guidelines, and Standard Operating.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing. Plans, organizes, coordinates, directs, tracks, and executes projects with clear objectives and timely deliverables. Provides leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce. Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers. Assures compliance to corporate policies and local standard operation procedures as well as domestic and international standards. Participates in cross-functional teams on new product development. Interacts with internal departments and external customers; particularly in problem resolution. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations. Contributes to the generation of ideas and potential inventions to be used in new products. Prepares patent disclosures, journal publication submissions, and presentation abstracts. Keeps abreast of relevant technology through literature and conferences. Supervises and directs activities of group members. Develops qualification test plans. Maintains thorough lab notebook and design history files. Writes engineering reports, feasibility reports, and monthly reports. Maintains good documentation practices for all data forms, protocols, reports, Design History files, and laboratory notebooks. Responsible for monthly reports to R&D Department management and quarterly review presentations. Provides technical guidance. Assists with various projects as assigned. Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
May be responsible for the direct supervision of various levels of Biocompatibility staff.
Bachelors Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS: 6 8 years related experience. 3+ years supervisory or project/program management experience preferred. Must be familiar with FDA and ISO biocompatibility guidelines, regulations and other related requirements. Must have a strong scientific background that fully understands the operation of an analysis laboratory. Able to review and approve biocompatibility test protocols for chemical analysis, toxicity tests, biological tests, and hemocompatibility tests. Strong oral and written communication skills.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
:Research and Development