Bioprocess Equipment Engineering Manager

Sepragen Corporation; Union City (CA); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Disability insurance

PTO

401K (match)

Job summary

Sepragen Corporation in Union City, CA, seeks a Mechanical Engineering Manager to lead bioprocess and biomedical equipment design, development, and manufacturing. The role demands hands-on leadership of a multidisciplinary team, delivering state-of-the-art systems on tight budgets and schedules.

You will oversee projects from concept through verification, ensure regulatory compliance (ASME BPE, ISO 13485, cGMP, CE, FDA), and mentor engineers to build a high-performance organization in the

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field; Master’s degree preferred.
• Minimum of 10 years of experience in mechanical engineering, with at least 5 years in leading teams to deliver projects on time.
• Experience in designing and developing bioprocess equipment, including automated electro-mechanical or fluid handling systems.
• Strong communication and leadership abilities, with a track record of building high-performing teams.

Responsibilities

• Oversee design and development of bioprocess and biomedical equipment ensuring scalability, manufacturability, and compliance with industry standards.
• Lead planning, execution, and delivery of mechanical engineering projects within timelines and budgets; coordinate cross-functional teams.
• Mentor and manage a multidisciplinary engineering team; recruit and retain top talent to meet milestones.
• Drive innovation and ensure designs comply with ASME BPE, ISO 13485, cGMP, CE, and FDA guidelines.

Skills

SolidWorks

AutoCAD

3D CAD

Project management

Leadership

Education

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Tools

SolidWorks

AutoCAD

Simulation tools

Job description

Sepragen Corporation in Union City, CA, seeks a Mechanical Engineering Manager to lead bioprocess and biomedical equipment design, development, and manufacturing. The role demands hands-on leadership of a multidisciplinary team, delivering state-of-the-art systems on tight budgets and schedules.

You will oversee projects from concept through verification, ensure regulatory compliance (ASME BPE, ISO 13485, cGMP, CE, FDA), and mentor engineers to build a high-performance organization in the