Job Description
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 and biomedical applications. This role involves managing engineering projects, ensuring adherence to quality and regulatory standards, and driving innovation to develop state-of-the-art equipment, such as bioreactors, diagnostic devices, and biomedical instruments. The ideal candidate will combine technical expertise with strong leadership capabilities to deliver cutting-edge solutions for the healthcare and life sciences industries.
Job Responsibilities
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.
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, software, manufacturing, and quality assurance.
Monitor project progress and address challenges proactively to ensure successful outcomes.
3. 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.
4. Compliance and Quality Assurance
Ensure that all designs comply with applicable industry standards and regulatory requirements, including ASME BPE, ISO 13485, cGMP, and FDA guidelines.
Conduct risk assessments (e.g., FMEA) and implement design controls to ensure product safety and reliability.
Collaborate with quality teams to conduct verification, validation, and testing activities.
5. Innovation and Continuous Improvement
Drive innovation in the design and development of bioprocess and biomedical systems to improve performance and cost-effectiveness.
Implement lean engineering principles to enhance workflow efficiency and reduce development timelines.
Stay updated on emerging trends, materials, and technologies to maintain a competitive edge in product offerings.
6. Stakeholder Collaboration
Act as a technical leader and liaison between engineering, manufacturing, quality vendors and clients.
Collaborate with clients to define technical requirements and provide solutions tailored to their needs.
Present project updates, technical solutions, and strategic recommendations to senior management and external stakeholders.
Numbers & Facts
| Location | Union City, CA |
| Job Type | Full-time |
| Salary | $140,000–$160,000 Per Year |
| Company Size | 11 - 50 |
| Headquarters | Union City, CA, US |
| Website | https://Www.Sepragen.com |
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 a leadership or managerial role.
Proven experience in designing and developing bioprocess or biomedical equipment, including familiarity with static and dynamic mechanicals, fluid dynamics and precision manufacturing.
Demonstrated expertise in managing complex engineering projects and delivering innovative solutions.
Good working relationships with and management of vendors, fabricators and suppliers.
Benefits
Paid Time-Off, Military Leave, 401K Match, Stock Options, Employee Events, 401K, Parental Paid Leave, Medical, Dental, Vision
About Company
Sepragen Corporation, headquartered in Union City, California, is an established biotechnology equipment company specializing in innovative bioprocessing and chromatography technologies. Founded in 1985, Sepragen develops and manufactures advanced equipment and solutions used in the development and production of biological drugs, vaccines, diagnostics, and other life-science products.
As the original inventor of radial flow chromatography, Sepragen has a long history of innovation in bioprocessing. The company’s product portfolio includes automated chromatography systems, chromatography columns and resins, buffer preparation systems, column packing systems, bioreactors, and customized engineering solutions designed to help customers increase productivity, reduce manufacturing footprint, and efficiently scale processes from laboratory development to commercial production.
Sepragen’s technologies are used by leading biotechnology and pharmaceutical organizations around the world in the manufacture of FDA-approved biologics and vaccines. The company combines engineering, manufacturing, and life-science expertise to develop high-quality solutions that help customers bring important biological products to market efficiently and cost-effectively.
At Sepragen, employees work in a collaborative, hands-on environment where innovation, quality, teamwork, integrity, and customer service are highly valued.
Skills
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