Mechanical Engineering Manager

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 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.

Key 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.

Pay: $140,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Work Location: In person