- 194919 - Program Manager
- CA-Bay Area
- $70 to $80.00 DOE
Chipton-Ross is seeking a Program Manager for an opening in Fremont, CA.
The Niche Diagnostics Program Management Office (PMO) is seeking a Program/Project Manager Consultant who will lead complex New Product Development projects and/or design changes to successful and timely completion. This role will lead cross-functional teams for In Vitro Diagnostics (IVD) devices in accordance to FDA, ISO 13485, and international regulations, as well as company Design Control procedures and phase gate approval processes.
• Build and maintain project timelines ensuring project tasks, dependencies and responsibilities are well defined. Utilize critical path techniques in schedule development and project monitoring.
• Maintain project budgets in collaboration with Finance and cross-functional departments.
• Estimate resource requirements, identify resource gaps, and work with management to address resource constraint issues.
• Facilitate the completion of various design control documents (project plans, design inputs, design outputs, risk, etc) and maintain design history files to ensure adherence to quality procedures.
• Identify, document, and mitigate project risks and contingency plans.
• Drive and track project team decisions.
• Proven track record of leading cross-functional teams, influencing business partners and get results through others.
• Solid ability to lead complex projects and virtual project teams.
• Outstanding interpersonal and organizational skills with the ability to multi-task and balance sophisticated and routine work activities.
• Strong conflict resolution skills.
• Clinical Diagnostics Division.
• 10 year industry experience; 5+ years in Project/Program Management
• Experience working in an FDA regulated environment is required.
• Advanced understanding of design control quality standards and regulatory compliance requirements for medical device or diagnostics (ex. 510K submissions). Experience in developing Therapeutic Drug Monitoring (TDMs) Tests, Infectious Disease Tests, Toxicology Tests, QC Controls, or Companion Diagnostic test is preferred.
• Strong understanding of product development challenges and methods for resolution.
• Proficient in MS Project and/or Smartsheets scheduling tools.
• Bachelor’s degree is required. PMP (Project Management Professional) certification recommended.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x242 or (800) 927-9318 x242
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.