Program Manager

Description

Pay: BR

Hours: M - F

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding BR billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information:

• Fremont, CA - OR - Remote in CA. for qualified candidate
• Clinical Diagnostics Division

How will you make an impact?

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.

What will you do?

• 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.

How will you get there?

Education/Experience:

• Bachelor's degree is required. PMP (Project Management Professional) certification recommended.
• 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.

Non-Negotiable Hiring Criteria:

• 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.

Skill/Experience/Education
Program Manager- Consultant
Contingent Hourly (CWHR)-TEM.CWHR.A00
Special Needs