Engineering Design Manager

• Provide expertise in:

Are you the engineer others call when the design challenge seems impossible?

Can you lead multidisciplinary teams and guide clients through the complexities of medical device development and commercialization?

Do you want to apply your expertise across surgical devices, drug delivery systems, diagnostics, and emerging healthcare technologies?

We are seeking a Manager of the Mechanical Design Engineering team with a primary focus on medical device and healthcare product development. This is a senior-level consulting and technical leadership role for a recognized engineering expert who thrives on solving complex product development challenges in highly regulated environments. As one of the firm's most experienced engineers, you will lead multidisciplinary teams, mentor talented technical associates and engineers, and serve as a trusted advisor to clients developing next‑generation medical devices, surgical technologies, drug delivery systems, diagnostic products, and other healthcare solutions.

You will guide projects from early innovation and concept development through design verification, validation, regulatory submission support, manufacturing transfer, and commercialization. Success in this role requires deep expertise in mechanical design, product development, risk management, human factors, and engineering within regulated medical device environments.

• Serve as a senior technical authority for medical device and healthcare product development programs.
• Lead and mentor a team of talented engineers, designers, and technical associates, fostering a culture of innovation, technical excellence, accountability, and continuous learning.
• Provide technical oversight on the most complex client engagements involving medical devices, drug delivery systems, surgical instruments, diagnostics, and combination products.
• Guide engineering teams through challenging design decisions, risk assessments, and regulatory requirements.
• Conduct high‑level design reviews and provide technical leadership throughout the product development lifecycle.
• Support recruiting, mentoring, coaching, and development of future technical leaders within SES.

• Lead the design and development of Class I, II, and III medical devices from concept through commercialization.
• Provide expertise in:
  • Design Controls
  • Risk Management (ISO 14971)
  • Human Factors Engineering
  • Verification & Validation
  • Design for Manufacturability (DFM)
  • Design for Assembly (DFA)
  • Reliability Engineering
  • Product Lifecycle Management
• Develop innovative solutions for surgical, orthopedic, cardiovascular, diagnostic, pharmaceutical, and drug delivery applications.
• Lead cross‑functional teams through product development activities, including design reviews, failure investigations, testing strategies, and regulatory submissions.
• Design and oversee development of prototypes, test fixtures, and verification methods.
• Evaluate product performance using engineering analysis, testing, and data‑driven methodologies.

• Serve as a trusted engineering advisor to medical device manufacturers, pharmaceutical companies, and healthcare technology organizations.
• Lead executive‑level technical discussions with clients regarding product development strategies, design risks, testing approaches, and commercialization plans.
• Present technical recommendations and engineering findings to technical, operational, quality, and executive stakeholders.
• Support business development efforts and build long‑term relationships within the medical device and healthcare industries.

• Bachelor's, Master's, or PhD in Mechanical Engineering, Biomedical Engineering, or related engineering discipline from an ABET‑accredited institution.
• Professional Engineer (PE) license required.
• 15+ years of progressive experience developing medical devices within regulated environments.
• Extensive experience leading product development programs from concept through commercialization.
• Demonstrated expertise in FDA‑regulated product development processes and Design Controls.
• Experience leading multidisciplinary…