Mechanical 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

Mechanical Engineering Manager – Bioprocess Equipment

Sepragen Corporation seeks a passionate, hard -working (50 hours/week), results-oriented and deadline-driven Mechanical Engineering Manager who is excited about leading this critical team to develop cutting edge products for the world’s leading customers in this field of advance medicine. Excellent technical design skills, strong work ethic, and good leadership, organization and communication skills are all essential for the successful candidate.

Job Description

Position Overview

The Mechanical Engineering Manager for Bioprocess and Biomedical Equipment will lead a team of engineers in the design, development, and manufacturing of advanced systems for bioprocessing applications. This role involves managing multiple engineering projects, simultaneously, driving innovation to develop state-of-the-art mechanical or automated equipment, such as bioprocess chromatography and TFF systems, columns, bioreactors and related equipment. The ideal candidate will combine technical expertise with strong leadership capabilities to deliver cutting-edge solutions for the healthcare and life sciences industries on a timely basis and within tight budgets.

Key Responsibilities

1. Design and Development

• Oversee the design and development of bioprocess and biomedical equipment, ensuring scalability, manufacturability, and compliance with industry standards.
• Utilize advanced modeling tools (e.g., SolidWorks, AutoCAD) to develop detailed 3D designs, simulations, and prototypes.
• Optimize mechanical systems for functionality, efficiency, and reliability under operating conditions.

2. Project Management

• Lead the planning, execution, and delivery of mechanical engineering projects, ensuring timelines, budgets, and technical specifications are met.
• Coordinate cross-functional teams, including process engineering, electrical engineering, PLC, software, manufacturing, and quality assurance.
• Monitor project progress and address challenges proactively to ensure successful outcomes.
• Interface with customers on Project plans, design and status reviews and documentation.

3. Leadership and Team Development

• Oversee, mentor, and manage a multidisciplinary team of mechanical engineers, fostering growth and collaboration.
• Define team objectives and individual responsibilities to meet project milestones and organizational goals.
• Recruit, train, and retain top engineering talent to build a world-class team.

5. Innovation, Quality and Continuous Improvement

• Drive innovation in the design and development of bioprocess systems to improve performance and cost-effectiveness.
• Ensure that all designs comply with applicable industry standards and regulatory requirements, including ASME BPE, ISO 13485, cGMP, CE, and FDA guidelines.
• Conduct design reviews and risk assessments, implement design controls and change controlto ensure product robustness and life cycle management.
• Collaborate with internal quality teams and clients to conduct verification, validation, and testing activities.

Qualifications

Education

• Bachelor’s degree in Mechanical Engineering or a related field (Master’s degree preferred).

Experience

• Minimum of 10 years of experience in mechanical engineering, with at least 5 years in inspiring and leading team to deliver successful and timely project outcomes.
• Proven experience in designing and developing bioprocess equipment, including familiarity with automated electro-mechanical or fluid handling systems and precision manufacturing.
• Demonstrated expertise in managing complex engineering projects and delivering innovative solutions.
• Good working relationships with internal team members, vendors, fabricators and suppliers.

Skills

• Strong proficiency in CAD software (e.g., SolidWorks, AutoCAD) and simulation tools. Microsoft Office, Excel, Gannt Charts, Sharepoint required.
• In-depth knowledge of materials used in bioprocess and biomedical applications, including stainless steel, polymers, and elastomers. Experience with designing molding, 3D printing, Ultrasonic welding, SS and plastic machining and welding.
• Familiarity with process flow sensor instrumentation and common testing equipment.
• Exceptional problem-solving, organizational, and project management skills.
• Excellent communication and leadership abilities, with a track record of building high-performing teams.

Certifications (Preferred)

Professional Engineer (PE) license or equivalent. Project Management Professional (PMP) certification. Certification in ASME Bioprocessing Equipment (BPE) standards.

Sepragen Corporation is an established, fast-growing provider of cutting- edge, world class and innovative process chromatography equipment to the bioprocess market. Our equipment is used in the manufacture of many life-saving biopharmaceuticals world-wide.

Position: This is a Full time, on-site (Union City, CA), exempt position with min 50 hours/ wk., occasional weekend, occasional domestic or international travel. Must self-relocate, be willing to commute and have reliable transportation.

Compensation: Salary $140,000-$165,000; Benefits: Health, Dental, Vision, Disability, PTO, 401K (match). Must have permission to work in the United States.

Disclaimer: This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties.

About Sepragen

Sepragen Corporation is an established, fast-growing provider of cutting-edge, world class and innovative bioprocess equipment for the biopharma market. Our products are used in the manufacture 35 commercially approved biologics and vaccines. Sepragen is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.