Staff Mechanical Design Engineer

Pro-Dex, Inc.; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Pro-Dex, Inc. is seeking a Staff Mechanical Design Engineer to lead the design, development, and continuous improvement of mechanical and electro-mechanical medical device systems across the product lifecycle, from feasibility to post-market support.

You will create CAD models in SolidWorks, conduct tolerance analyses, participate in risk assessments and design reviews, and collaborate with suppliers and cross-functional teams to ensure compliant, manufacturable solutions.

Qualifications

• BS in Mechanical Engineering or related field.

Responsibilities

• Lead and assist in mechanical/electromechanical design from concept to commercialization.
• Create CAD models and detailed drawings using SolidWorks.
• Identify and resolve design issues related to performance, manufacturability, inspection, and assembly.
• Analyze test data to ensure designs meet specifications.
• Collaborate with engineers, machinists, inspectors, and assemblers to translate designs into devices.
• Document and release design work per QMS with proper design control.
• Develop risk assessments, design reviews, and failure analyses.
• Work with suppliers to source components and resolve manufacturing concerns.
• Identify continuous improvement opportunities for device designs and QMS procedures.
• Ensure compliance with policies, procedures, and regulatory requirements.
• Lead team meetings and drive collaborative decision-making.

Skills

SolidWorks

Medical device development

GD&T

DFMIA

Tolerance analyses

Statistical analysis

MS Office

Project management

Team collaboration

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

MS Project

MS Office

Job description

JOB SUMMARY

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.

JOB DUTIES

• 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 SolidWorks.


• Identify and resolve design issues related to performance, manufacturability, inspection, and assembly.


• Analyze and interpret test data to establish that designs meeting 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.

SKILLS AND QUALIFICATIONS

• Experience with SolidWorks 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.

ACCOUNTABILITIES

• 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.

EDUCATION AND EXPERIENCE

• 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.

INTERPERSONAL AND COMMUNICATIONS SKILLS

• 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.

MENTAL, PHYSICAL AND VISUAL DEMANDS

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility and must be capable of using a keyboard for computer purposes. This role may The employee may be required to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification.

We are an Equal Employment Opportunity ("EEO") Employer.

We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time.