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Sr. R&D Project Manager

Company: BD
Location: Salt Lake City
Posted on: June 12, 2021

Job Description:

Job DescriptionSupport of EU-MDR submissions: Coordinates and/or directs all R&D activities surrounding EU-MDR submission of Oncology products.Product Remediation: coordinates and/or directs all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals. ProjectManagement: creates, tracks and meets project schedules. Creates strategic plans and budgets for EU-MDR and assesses priorities and makes assignments to direct reports to ensure project and company priorities are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.Design to Manufacturing Transfer: proposes and facilitates product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.Documentation: Support teams by reviewing product development plans and participate in design reviews, review and approve technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy.Test Method Development: oversee the development of clinically relevant test methods that adequately challenge product design and processes.Testing: Plan, develop, execute and manage verification and validation activities for products and processes in support of EU-MDR requirements.Training: train technicians and engineers on design and process development and provide input to training of division procedures and policies.Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through Product Development/Improvement/Maintenance activities. Typically supervises/manages various members of a R&D department, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.Fiscal: Creates, controls, manages a project budget (expense and capital expenditure). Create and critique engineering cost analysis. Reviews and analyzes costs to identify and implement cost improvements.Other Responsibilities may include, however are not limited to:Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.Required Qualifications:B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Exposure to Biomedical Engineering or Bioengineering is a plus.Experience: 8-11 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 6-8 years or Ph.D. degree with 4-6 years, medical device or equivalent industry experience). A minimum of 4 years experience in a supervisory capacity.Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required.Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.Ability to create and execute project plans and lead cross functional teams.Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management.Strong ability to analyze and use technical data and resources. Proficient in statistical analysis and related software.Preferred Qualifications:Masters degree in relevant engineering discipline.Project Management Professional (PMP) or Scrum Master (PSM1) qualified.Training in Six Sigma or Design for Six Sigma.Knowledge of cGMP and GLP is a plus.Education and/or Experience:B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Exposure to Biomedical Engineering or Bioengineering preferred.Experience: 8-11 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 6-8 years or Ph.D. degree with 4-6 years, medical device or equivalent industry experience). A minimum of 4 years experience in a supervisory capacity.Physical Demands:While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.Work Environment:While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.#LI-PROby Jobble Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

Keywords: BD, Salt Lake City , Sr. R&D Project Manager, Other , Salt Lake City, Utah

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