Engineering Design Manager

About the role

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.

Responsibilities

• 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.

  Qualifications

  • 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 engineering teams and mentoring technical professionals.
  • Strong understanding of product risk management, verification, validation, and quality systems.
  • Proven track record of successful client engagement and technical leadership.
  • Exceptional written, verbal, and presentation skills.
  • Able and willing to serve in a highly client-facing consulting role.
  • Authorized to work in the United States without sponsorship.