Sr Manager Design and Construction (MedTech)

Location: US - California - San Diego; onsite role

Base salary: $155,600–$233,400 per year, plus variable cash programs and possible equity.

Company

hirify.global develops genomic technology, sequencing solutions, and genetic analysis systems aimed at improving disease detection, diagnosis, and treatment.

What you will do

• Manage and develop a mid-size team of 6–10 employees through coaching, performance management, recruiting, and training.
• Establish strategic goals, define objectives, evaluate outcomes, and communicate achievable timelines and plans.
• Ensure validation programs meet FDA, ISO, IEC, and MDSAP requirements.
• Lead audit readiness, validation engineering development, process standardization, and documentation.
• Support verification testing and collaborate with development, manufacturing engineering, scientists, technicians, marketing, and project management.
• Lead cross-functional teams addressing system issues and delivering genetic analysis systems.

Requirements

• 5–7 years of experience managing a mid-size team, including coaching, mentoring, development, and performance management.
• 5–7 years of manufacturing, quality assurance, or engineering experience in an FDA-regulated environment.
• Experience in medical device or IVD development, quality systems, process controls, continuous improvement, and audit support.
• Working knowledge of FDA 21 CFR Part 11 and Part 820, ISO 9001/13485, IEC 62304, MDSAP, and validation principles.
• Experience with FMEA, risk analysis, CAPA, and medical device manufacturing processes.
• Strong analytical, verbal, written, cross-functional, and technical communication skills.

Nice to have

• Experience transitioning an RUO manufacturing line to Dx/IVD control.
• Experience with statistics, Statistical Process Control, and DOE techniques.
• Six Sigma Black Belt, PMP, or ASQ accreditation.

Culture & Benefits

• Inclusive environment focused on belonging, collaboration, openness, and diverse perspectives.
• Health, dental, and vision coverage, retirement benefits, paid time off, and family planning support.
• Access to genomics sequencing and employee resource groups supporting career development and social responsibility.
• This role is not eligible for visa sponsorship.
• Background checks may be conducted after a conditional offer.