Sepragen Corporation
Mechanical Engineering Manager
Sepragen Corporation, Union City, California, United States, 94587
Overview
Mechanical Engineering Manager – Bioprocess Equipment role seeking a passionate, hard-working (50 hours/week), results-oriented leader to guide a team developing cutting-edge bioprocess equipment for healthcare and life sciences industries. Position : Mechanical Engineering Manager – Bioprocess and Biomedical Equipment. Location: Union City, CA. Type: Full-time, on-site, exempt. Occasional weekend, domestic or international travel. Must relocate or commute with 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 a summary of typical functions of the job, not an exhaustive list of all responsibilities, tasks, and duties. 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 control to 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, Gantt 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. 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 of life-saving 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. EEO : Sepragen is an equal opportunity employer. Applied Details
Note: This listing includes on-site requirements and travel expectations. Benefits and compensation are indicative and may change with role and experience.
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Mechanical Engineering Manager – Bioprocess Equipment role seeking a passionate, hard-working (50 hours/week), results-oriented leader to guide a team developing cutting-edge bioprocess equipment for healthcare and life sciences industries. Position : Mechanical Engineering Manager – Bioprocess and Biomedical Equipment. Location: Union City, CA. Type: Full-time, on-site, exempt. Occasional weekend, domestic or international travel. Must relocate or commute with 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 a summary of typical functions of the job, not an exhaustive list of all responsibilities, tasks, and duties. 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 control to 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, Gantt 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. 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 of life-saving 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. EEO : Sepragen is an equal opportunity employer. Applied Details
Note: This listing includes on-site requirements and travel expectations. Benefits and compensation are indicative and may change with role and experience.
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