Manager, Mechanical Design Engineering

Stress Engineering Services, Inc.; Mason (OH); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Employee-owned culture (ESOP)

Thought Leadership

Job summary

Stress Engineering Services (SES) seeks a Manager of the Mechanical Design Engineering team focused on medical device and healthcare product development. You will lead multidisciplinary teams, guide clients through complex regulatory landscapes, and mentor engineers across surgical devices, drug delivery, diagnostics, and related healthcare technologies.

As a senior technical authority, you will oversee projects from concept through verification, validation, regulatory submissions, manufacturing

Qualifications

• Bachelor’s, Master’s, or PhD in Mechanical or Biomedical Engineering from ABET-accredited institution.
• PE license required.
• 15+ years of progressive experience developing medical devices in regulated environments.
• Experience leading product development programs from concept through commercialization.
• Demonstrated FDA-regulated product development & Design Controls expertise.
• Experience leading multidisciplinary engineering teams and mentoring professionals.
• Strong risk management, verification/validation, and quality systems knowledge.
• Proven client engagement and technical leadership.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Serve as a senior technical authority for medical device and healthcare product development programs.
• Lead and mentor engineers, fostering innovation, excellence, accountability, and learning.
• Provide oversight on complex client engagements across devices, drug delivery, diagnostics, and combination products.
• Guide teams through design decisions, risk assessments, and regulatory requirements.
• Perform high-level design reviews throughout the product development lifecycle.
• Support recruitment and development of future technical leaders within SES.
• Lead cross-functional product development activities and regulatory submissions.

Education

ABET-accredited Mechanical or Biomedical Engineering

Professional Engineer (PE) license

15+ years medical device development experience

Tools

SolidWorks

Python

MATLAB

Minitab

JMP

Job description

• 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?

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

The Opportunity

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.

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.

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.

Why Join SES

• 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 - You’ll have the opportunity to contribute to meaningful engineering insights, share your expertise with the broader industry, and build credibility as a trusted technical voice.

What’s in it for you?

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.

We offer a comprehensive and competitive benefits package, including medical, dental, and vision coverage, paid time off, and holidays. Your compensation is thoughtfully aligned with your experience, expertise, and the value you bring to the team.

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. If you’re driven by meaningful work, a strong team, and the opportunity to think like an owner, you’ll thrive at Stress Engineering.

Recruitment Process Disclosure

As part of your candidacy and potential future employment, you agree to maintain the confidentiality of proprietary, sensitive, and client-related information obtained through interactions with SES. This obligation applies during and after your engagement.

As part of our hiring process, Stress Engineering Services may use technology tools, including automated tools, to help organize, review, or evaluate application materials and interview-related information. These tools are used to support our recruiting process, but hiring decisions are not made solely by technology. If you need would like to request a reasonable accommodation or would like additional information about the process, please contact [e-mail]. Where applicable required by law, we will provide additional notices if a specific tool analyzes interview responses, assessments, or other information as part of your evaluation.

Equal Opportunity Employer

Stress Engineering Services, Inc. (SES) is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other protected characteristics.