Mechanical Engineering Manager, Bioprocessing Instrumentation

Sepragen Corporation seeks a passionate, hands-on, hard -working, 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. Teamwork, integrity and good communication skills are essential for the successful candidate.

Summary Job Description:

The Mechanical Engineering Manager will lead a team of engineers in the design, development, and manufacturing of advanced electromechanical systems with single or multi-use use fluid handling used in bioprocessing. 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 chromatography, filtration and bioreactor instruments. The ideal candidate will combine technical expertise with strong leadership capabilities to deliver cutting-edge solutions for the healthcare and life sciences industries.

Responsibilities

Key Responsibilities:

1.  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 bioprocessing and biomedical equipment, ensuring scalability, manufacture-ability, 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 bioprocessing 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.

Essential 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.

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 instrumentation and common testing equipment.
• Familiarity with regulatory standards such as ASME BPE, ISO 13485, cGMP, and FDA, CE, NRTL certifications around Hazex requirements useful.
• 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.

Physical Requirements:

If the role has any physical demands, include them here to comply with ADA regulations and ensure potential applicants understand the expectations.

• Ability to lift 30 pounds, if applicable.
• Standing, sitting, or walking for extended periods.

Work Environment:

• Office-based role with occasional travel to manufacturing sites, client facilities, or industry events.
• Interaction with cross-functional teams in a collaborative and fast-paced environment.

Benefits:

• Salary Range: $145,000-$175000 per year including potentially stock options.
• Comprehensive health, dental, and vision insurance.
• Opportunities for professional development and training in bioprocess and biomedical engineering.
• PTO, Holiday Pay, EAP, 401k, 401k Matching

Equal Opportunity Employer:

Sepragen Corporation is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to creating a workplace based on diversity and inclusion, and we comply with all California labor regulations and federal employment laws.

About the Company:

 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 many FDA approved biologics world-wide, as well as high profile manufacturing of leading Covid vaccines, insulin and cutting edge gene therapy and mRNA based products.

Apply today and help save a life!

Email Resume to: gpanzarini@sepragen.com