Sr. Mechanical Engineer

Title: Senior Engineer– Medical Device Product Development

We are seeking a highly hands-on and technically skilled Senior Engineer to support the development of innovative medical devices and complex product subsystems. This role is ideal for an engineer with strong mechanical design fundamentals, rapid prototyping expertise, and practical experience developing products in a fast-paced medical device environment.

The ideal candidate is a collaborative problem solver with experience designing, building, testing, and refining precision components and assemblies for minimally invasive or endoscopic medical device applications.

Key Responsibilities

• Contribute to the design and development of medical device products and subsystems from concept through commercialization.
• Create detailed mechanical designs, prototypes, and engineering solutions for complex product challenges.
• Perform hands-on prototyping, assembly, testing, debugging, and design iteration activities.
• Design and build test fixtures and equipment to support characterization studies, verification testing, and Design of Experiments (DOE).
• Support development of molded, machined, and precision mechanical components and assemblies.
• Collaborate with manufacturing, quality, supplier, and cross-functional engineering teams to optimize product performance and manufacturability.
• Apply engineering fundamentals to support tolerance analysis, stress analysis, and design optimization activities.
• Participate in design reviews, root cause investigations, and technical problem-solving efforts.
• Support Design for Manufacturing (DFM) and Design for Assembly (DFA) initiatives throughout development.
• Document engineering activities and support verification and validation efforts in compliance with medical device development processes.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering or related engineering discipline.
• 5–8 years of engineering experience, preferably within the medical device industry.
• Strong hands-on engineering and product development experience.
• Skilled in rapid prototyping and iterative product development.
• Experience designing precision machined and molded plastic components.
• Experience building and executing test fixtures and DOE-based experiments.
• Working knowledge of tolerance analysis, GD&T, and stack-up analysis.
• Understanding of Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
• Familiarity with mechanical stress analysis and engineering calculations.
• Proficiency with CAD modeling and mechanical drawing creation.
• Strong analytical and technical problem-solving skills.
• Excellent communication and teamwork skills.

Preferred Qualifications

• Experience with minimally invasive, endoscopic, or endoluminal medical devices.
• Familiarity with catheter-based systems or disposable medical devices.
• Experience working in regulated product development environments.
• Exposure to verification and validation testing methodologies.
• Experience supporting pilot builds or manufacturing transfer activities.

Desired Attributes

• Highly hands-on and execution-oriented.
• Strong mechanical intuition and practical engineering judgment.
• Curious, adaptable, and eager to learn.
• Collaborative team player with strong attention to detail.
• Comfortable working in fast-paced engineering development environments.
• Passionate about building innovative medical technologies and solving complex technical challenges.