Medical Device Design Engineer - SolidWorks & Regulatory

Ki Mobility Llc; Stevens Point (WI); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Ki Mobility in Stevens Point, Wisconsin, is seeking a Design Engineer to join the product development team. You will lead design tasks, develop new products, and create production-ready drawings using SolidWorks, while ensuring compliance with ISO 13485 and FDA 21 CFR 820.

You will collaborate with cross-functional teams to optimize designs for manufacturability and cost, maintain design history files, and contribute to verification/validation activities.

Formación

• Bachelor degree in Mechanical Engineering or related field, or 1-3 years of related experience.
• 3+ years of CAD-based mechanical design experience.
• 1-3 years in the medical device industry (Class I) preferred.
• Willing to travel up to 10% domestically and internationally.

Responsabilidades

• Develop design solutions for defined product requirements in regulated medical devices.
• Lead engineering input through new product development and design changes.
• Create and manage complex 3D SolidWorks models and production drawings.
• Organize design data and ensure design history files comply with ISO 13485 and FDA standards.
• Prepare BOMs, work instructions, test plans and design reviews.
• Collaborate with cross-functional teams to support design, validation, and release to production.
• Support verification and validation through prototypes and production samples.

Conocimientos

ISO 13485 knowledge

DFMEA

3D CAD design

GD&T

Technical writing

Cross-functional teamwork

Communication skills

Educación

Bachelor degree in Mechanical Engineering or related Engineering Technology degree

Herramientas

SolidWorks

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Design Engineering Indirect Full Time Stevens Point, WI, US

30+ days ago Requisition ID: 1638

Job Summary

A key member of the product development team, the Design Engineer develops both new product design and design changes, leading engineering tasks and support through production. A focus on creative design solutions to meet product requirements using resources such as CAD tools and analysis techniques coupled with an understanding of materials, manufacturing processes, tool design, and cost of production. An additional focus is to ensure technical documentation is completed to fulfill the requirements of the design history file, following established design controls to meet medical product regulatory compliance requirements.

Essential Functions

Job Responsibilities

• Develop design solutions to meet defined product requirements within a regulated medical device industry.
• Lead engineering input through new product development and design changes.
• Create, refine, and manage complex 3D product solid models using SolidWorks.
• Produce detailed drawings for production specifications.
• Organize and maintain accurate documentation, design data, and digital records for design history files in accordance with ISO 13485 and FDA (21 CFR Part 820) standards.
• Prepare technical documentation such as BOM, work instructions, test plans, test reports, risk analysis, labeling, product acceptance criteria, and design reviews.
• Contribute to cross-functional new product development teams, supporting design, validation, and release to production.
• Assemble prototypes and production samples for verification and validation to confirm product meets requirements and standards.
• Optimize designs for manufacturability, cost efficiency, and reliability.
• Plan, prioritize, and coordinate work activities to meet project deadlines and deliverables.
• Stay current on emerging medical device technologies, materials, and regulatory trends to support organizational goals.
• Ensure and follow safety requirements and standards.
• Adhere to Company’s Quality Management System requirements.
• Maintain a safe, neat, and orderly work environment.
• Perform all duties in a manner that follows, demonstrates, and promotes Company’s values.
• Report to work as scheduled, on time, and able to work entire work schedule.
• Perform additional duties as assigned.

Knowledge, Skills, and Ability

• Knowledge of medical device regulations (ISO 13485) and quality systems.
• Ability to leverage creativity and resourcefulness in applying design concepts through development to production.
• Product design skills and mechanical aptitude with a working knowledge of component manufacturing processes for both metals and plastics.
• Ability to develop and carry out testing to verify and validate designs.
• Ability to apply analytical techniques to design and risk analysis, such as DFMEA.
• Strong proficiency in 3D CAD design and modeling, with expertise in SolidWorks.
• Strong drafting proficiency, including dimensioning and tolerancing (GD&T).
• Proficiency in Microsoft Office Suite and digital file management.
• Organized and detail oriented, with solid technical writing skills.
• Team oriented with the ability to lead engineering effectively in a cross-functional team environment.
• Ability to work effectively both independently and within a team environment.
• Ability to effectively present information and respond to questions in meetings and design reviews.
• Possess a continuous improvement mindset.
• Possess effective written and oral communication skills.
• Ability to be highly adaptable and responsive to changing business needs.
• Ability to obtain a passport if needed for international travel.
• Ability to observe and identify details.
• Ability to effectively communicate and perceive information.
• Ability to work extended hours as scheduled, including weekends.

Physical Demands

• Frequent sitting, wrist manipulation, walking, and standing.
• Frequent sedentary work with lifting up to 10 pounds.
• Occasional medium work with lifting up to 40 pounds.
• Manual dexterity to type and operate office equipment occasionally.
• Manual dexterity to use hand tools for assembly and measuring.
• Must be able to complete all physical requirements to perform the essential functions.

Qualifications

Education/Education

• Bachelor degree in Mechanical Engineering or related Engineering Technology degree, or 1-3 years of related experience.
• Experience in CAD environment with preference of 3+ years’ experience in mechanical design.
• 1-3 years of experience in the medical device industry (Class I) preferred.
• Standard working conditions include a temperature-controlled office environment and manufacturing environment.
• Position may include occasional domestic and international travel up to 10%.

This position does not now or in the future provide immigration sponsorship.

This position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.

Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.