Senior Principal Mechanical Design Engineer

About Stress Engineering Services

Stress Engineering Services (SES) is an elite, one-of-a-kind engineering consulting firm, trusted for more than 50 years to solve the problems others can’t. Our reputation is built on an uncompromising commitment to technical excellence, a highly selective team of experts, and a track record of delivering answers in the most complex, high-stakes environments. We operate at the intersection of deep technical expertise and real-world application, partnering with clients across energy, aerospace, consumer products, medical, and beyond. Our teams combine advanced analysis with hands-on testing, failure analysis, and practical engineering judgment to deliver solutions that perform where it matters most—in the field.

As an employee-owned company, our people are personally invested in every outcome, creating a culture where accountability is high and excellence is the standard. We don’t just solve problems—we uncover root causes, mitigate risk, and deliver confidence. For our clients, that means a trusted partner known for rigor and results. For our people, it means joining an elite team tackling the most meaningful challenges in engineering. SES is where complex problems meet uncommon solutions—and where elite engineers come to do their best work.

Our Core Values

• We Over Me – We put the mission, our clients, and our team ahead of individual agendas
• Unyielding Pursuit of Excellence – Excellence is the standard. We deliver the right solution, on time, every time
• Own It – We take accountability to earn trust and deliver results

About the Role

We are seeking a Senior Principal Mechanical Design Engineer to join our Industrial & Product Design 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.

Responsibilities

Technical Leadership

• 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.

Medical Device Product Development & Design Excellence

• 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.

Client Leadership

• 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.

Requirements

Basic 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.
• Ability and willingness to serve in a highly client-facing consulting role.
• Authorized to work in the United States without sponsorship.

Preferred Qualifications

• Advanced degree (MS or PhD) in Mechanical Engineering, Biomedical Engineering, or related discipline.
• Expertise with FDA, ISO 13485, IEC 60601, ISO 14971, and other applicable medical device standards.
• Experience developing:
  • Surgical devices
  • Implantable products
  • Drug delivery systems
  • Combination products
  • Diagnostic devices
  • Pharmaceutical manufacturing equipment
• Strong knowledge of human anatomy, physiology, and surgical procedures.
• Experience supporting regulatory submissions and product approvals.
• Advanced CAD proficiency (SolidWorks preferred).
• Experience with statistical analysis, DOE, Python, MATLAB, Minitab, JMP, or similar tools.

What Makes You Successful In This Role

• Recognized technical expert within the medical device industry.
• Passionate mentor who enjoys developing engineers and technical associates.
• Strong balance of innovation, engineering rigor, and practical execution.
• Comfortable leading highly regulated, multidisciplinary product development efforts.
• Trusted by clients for technical excellence, sound judgment, and strategic insight.
• Driven to solve difficult healthcare challenges that improve patient outcomes and quality of life.

Benefits

• Solve problems that matter – Your work directly impacts product performance, safety, and reliability
• High autonomy + high ownership – You’re trusted to lead and deliver
• Broad technical exposure – Work across industries, materials, and challenges
• Collaborate with experts – Learn from recognized leaders in engineering and failure analysis
• Entrepreneurial environment – Be part of a team that values initiative, curiosity, and innovation
• Employee-owned culture (ESOP) – Share in the success you help create
• Thought Leadership - Opportunity to contribute to meaningful engineering insights, share your expertise with the broader industry, and build credibility as a trusted technical voice
• Comprehensive and competitive benefits package, including medical, dental, and vision coverage, paid time off, and holidays

At Stress Engineering, curiosity isn’t just encouraged, it’s expected. You’ll have the opportunity to deepen your technical expertise, broaden your industry exposure, and make a meaningful impact on real-world engineering challenges from day one.

Own your impact. Build your future. Here, employee ownership is more than a benefit—it’s part of our culture. The work you do today contributes to long-term success that you share in, alongside a team that values collaboration, innovation, and accountability. We’re built for stability and growth, where your technical skills and problem-solving directly influence outcomes—not just for individual projects, but for the future of the company.