Sr Manager Design and Construction

Senior Manager role overseeing design and construction operations at a genomics company. Leads mid-size teams on validation programs, quality systems, and manufacturing processes for medical devices in an FDA-regulated environment.

Responsibilities

• Manage staff performance through expectations-setting, monitoring, coaching, and developing improvement plans
• Establish strategic goals and evaluate outcomes using business and operations data
• Ensure validation programs meet FDA and international regulatory requirements
• Lead cross-functional teams on new product development and system issue resolution
• Estimate timelines and budgets for validation engineering efforts and standardize processes

Requirements

• 5-7 years managing teams of 6-10 people with coaching and mentoring ability
• 5-7 years in manufacturing, quality assurance, or engineering in FDA-regulated environments
• Medical device/IVD industry experience with quality systems and continuous improvement
• Working knowledge of FDA 21 CFR Part 11/820, ISO 9001/13485, IEC 62304, MDSAP
• Demonstrated expertise in validation principles, FMEA, risk analysis, and CAPA
• Strong analytical problem-solving and communication skills, both verbal and written
• Audit support experience (front and back room) in regulated manufacturing

Compensation: $155,600 - $233,400 base