JOB OVERVIEW:
The Designer supports the design, development, and continuous improvement of the company's growing product line through detailed CAD
modeling, drawing creation, prototyping support, and engineering documentation activities. This role focuses on translating engineering
concepts into manufacturable designs while supporting testing, production, and quality-system requirements. Success in this position requires
strong mechanical aptitude, attention to detail, and the ability to execute assigned design tasks under the guidance of engineering leadership.
This position reports directly to the Lead R&D Engineer.
JOB RESPONSIBILITIES AND DUTIES:
Consistently models the core values of the company both internally and externally.
Openly commit to and support company processes and systems.
Create and revise device components, assemblies, and systems using CAD software (SolidWorks) In support of engineering design
objectives.
Conduct prototype builds and assist with hands-on troubleshooting/root cause analysis on prototypes and commercial units.
Generate detailed engineering drawings, bills of materials (BOMs), and technical documentation to support manufacturing and
quality assurance.
Work with engineering, manufacturing, and quality teams to Implement design updates and resolve manufacturability or
documentation issues.
Participate in design reviews, feasibility studies, and testing activities supporting engineering-led development efforts.
Assist in the preparation of design verification and validation protocols, reports, and test documentation.
Support manufacturing by addressing day-to-day engineering questions, drawing clarifications, and design updates.
Assist with tolerance stack-up analyses, fit/function evaluations, and basic design-for-manufacturability assessments.
Support supplier communication related to drawing clarifications, part revisions, and technical inquiries.
Maintain organized project files and assist with preparation of technical documentation for regulatory submissions when required.
Key Metrics
Design Task Throughput: Timely completion of assigned design tasks and drawing packages
Documentation Accuracy: Quality and completeness of engineering drawings and technical documentation
Compliance Support: Adherence to quality-system and regulatory documentation requirements
QUALIFICATIONS / EDUCATION AND EXPERIENCE:
Technical Skills: Proficiency in CAD software (SolidWorks preferred) and DFM/DFA principles
Schematic Reading: Strong ability to interpret and create engineering drawings with GD&T (Geometric Dimensioning and Tolerancing)
Problem-Solving: Ability to troubleshoot design issues, optimize product performance, and resolve engineering challenges
Attention to Detail: Strong focus on accuracy in design specifications and documentation
Mathematical Skills: Proficiency in engineering calculations, material properties, and tolerancing
Communication: Clear verbal and written communication skills to collaborate with teams and document design processes
Teamwork: Ability to work in a cross-functional team environment and support product development efforts
Basic Computer Skills: Proficiency in Microsoft Office
Associate degree in Mechanical Design, Engineering Technology, or related technical discipline required.
JOB DESCRIPTION
Date: February 23, 2026
Experience: 2-4 years of mechanical design or CAD detailing experience, preferably in the medical device industry or other regulated
manufacturing industry
ADDITIONAL DESIRABLE QUALIFICATIONS SKILLS AND KNOWLEDGE:
Familiarity with ISO 13485-compliant design controls, documentation, and change-management processes
Ability to interpret and apply ASME Y14.5 principles in engineering drawings
PHYSICAL ACTIVITIES
The physical demands described here are representative of those that must be met by the employee to successfully perform the essential
functions of this position.
Body Positions: Regularly required sitting, standing, and walking for pro-longed periods of time
Body Movements: Full range of body movements including the use of hands and fingers to handle or feel objects, and bending,
reaching, lifting, and crouching
Vision: Ability to read and see instructions, computer screens, and small parts for assembly
MENTAL REQUIREMENTS
Attention to Detail: Must be able to focus on small details and ensure accuracy and precision in the assembly of components
Relational: Must be able to comfortably connect and work with different personalities both inside and outside the company
Communication Skills: Must be able to read and write clearly to effectively communicate with team members and supervisors
WORKING CONDITIONS
Environment: Work is performed in a typical assembly shop environment. The area is usually well lit and ventilated but may involve
exposure to moderate noise levels from machinery and equipment.
Physical Demands: This role involves standing, sitting, and performing repetitive tasks for extended periods. Manual dexterity is
required for handling small components and tools. One must be capable of lifting and moving objects up to 50 lbs.
Work Hours: Full-time position with standard working hours, typically Monday through Friday. Occasional overtime or weekend work
may be required to meet production deadlines.
Protective Gear: Use of personal protective equipment (PPE) such as safety glasses, gloves, and ear protection is mandatory to
ensure safety. Temperature: The temperature in the assembly shop may vary but is typically maintained at a comfortable level.
Occasional exposure to cooler or warmer conditions may occur depending on the season and ventilation.
Health and Safety: Strict adherence to health and safety guidelines is required to prevent accidents and ensure a safe working
environment for all employees. Regular training on safety procedures and emergency protocols is provided.