Staff Mechanical Design Engineer

Staff Mechanical Design Engineer

The Staff Mechanical Design Engineer is responsible for the design, development, and continuous improvement of mechanical and electro-mechanical medical device systems throughout the product lifecycle, including feasibility, concept development, detailed design, verification, design transfer, product launch, and post-market support.

As a senior member of the engineering team, this individual serves as a technical leader and mentor, providing guidance to junior engineers and influencing cross-functional teams in the identification, analysis, and resolution of complex technical challenges.

The Staff Mechanical Design Engineer collaborates closely with Engineering, Quality, Regulatory Affairs, Manufacturing, Machine Shop, and Production personnel to ensure products meet performance requirements, are manufacturable, and comply with applicable regulatory and quality standards. This role requires strong technical expertise, hands-on design and prototyping experience, and the ability to drive innovative solutions in a fast-paced, cross-functional environment.

• Lead and assist in the creation and development of mechanical and/or electromechanical designs and systems based on customer and/or internal requirements from concept to commercialization.
• Lead and assist in generation of new or revised CAD models and detailed engineering drawings using Solid Works.
• Identify and resolve design issues related to performance, manufacturability, inspection, and assembly.
• Analyze and interpret test data to establish that designs meet functional and performance specifications.
• Collaborate with other engineering team members, machinists, inspectors, and assemblers to translate designs into fully developed medical devices.
• Document and release design work through detailed drawings, models, technical analysis, and design control documentation in accordance with the QMS.
• Develop and participate in risk assessments, design reviews, and failure analyses.
• Effectively work with suppliers to source components, gather technical information, and/or resolve manufacturing and/or inspection concerns.
• Identify and propose solutions for continuous improvement opportunities for new and/or existing device designs and/or QMS procedures governing product development.
• Ensure that work complies with company policies, procedures, and applicable regulatory requirements.
• Attend and lead team meetings; drive and contribute to collaborative decision-making.
• Perform other duties as assigned.

• Experience with Solid Works or similar 3D CAD software is required.
• Experience with medical device development, design controls (21 CFR 820, ISO 13485), and risk management (ISO 14971) required. Complex medical device development experience (e.g. powered surgical devices) preferred.
• Fluent in application and interpretation of ASME Y14.5 Geometric Dimensioning & Tolerancing (GD&T).
• Application of Design for Manufacturability, Inspection, and Assembly (DFMIA) principles.
• Ability to plan and reduce technical design risks, including tolerance analyses, FEAs, characterization testing, etc.
• Ability to quickly gather and analyze sufficient data to provide direction and guidance for good decision making. Exposure to statistical analysis methods is a plus.
• Proficiency with Microsoft Office tools; familiarity with Microsoft Project or similar project management tools is a plus.
• Strong problem-solving, organizational, and communication skills.

• Take ownership of assigned projects with available resources and minimal guidance.
• Demonstrate initiative in learning and applying technical skills.
• Maintain documentation in accordance with regulatory and company standards.
• Collaborate and drive cross-functional teams to meet project goals and deadlines.
• Follow all safety, quality, and compliance protocols.

• Bachelor of Science (B.S.) Degree in Mechanical Engineering or a related field.
• Minimum 8 years of professional experience in product design or mechanical engineering (internship or co-op experience may be considered), knowledge of complex medical device development, including motor design/system integration preferred.

• Teamwork:
  Comfortable working in and influencing a fast-paced, collaborative environment with cross-functional teams.
• Communication:
  Able to clearly document and explain technical information to both technical and non-technical audience.
• Responsibility:
  Willing to take on assignments and follow through with minimal oversight.
• Professionalism:
  Ability to work respectfully and constructively with others, including when facing challenges or conflict.
• Resourcefulness:
  Demonstrates initiative in identifying solutions, gathering information, and overcoming obstacles independently or with minimal direction. Able to seek out internal and external resources to move projects forward efficiently.

While undertaking the essential duties…