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 FunctionsJob 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 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.
- Intermediate math proficiency.
- 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.
- 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.
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.
Skills Required
- Bachelor's degree in Mechanical Engineering or a related Engineering Technology degree, or 1–3 years of related experience
- Experience working in a CAD environment
- Strong proficiency with SolidWorks and 3D CAD design and modeling
- Strong drafting proficiency, including GD&T
- Knowledge of medical device regulations, ISO 13485, and quality systems
- Ability to develop and perform design verification and validation testing
- Ability to apply analytical techniques including DFMEA and risk analysis
- Three or more years of mechanical design experience
- One to three years of Class I medical device industry experience
- Ability to obtain a passport for international travel if needed
What We Do
Core Beliefs We Build It Better We understand that innovative design must always lead to a functional product that improves lives and makes mobility easier. From agility and maneuverability to structural integrity, strength and durability. We don’t just make wheelchairs, we make wheelchairs better. Relationships are Not One-Dimensional People are connected to people who are connected to other people—and the better we understand the full support systems that our end users rely on, the better we are able to serve our customers. We value our relationships and conversations with everyone who interacts with our products, from product designers and engineers to clinicians, complex rehab technology professionals and end users. It's a Trust Thing At Ki Mobility, service is part of the product. We understand that a great product experience—for customers and the people we serve—lasts a lifetime, from product specification, fitting and adjusting to training and maintenance. Finding the Right Fit What makes a wheelchair extraordinary is how well it fits the needs and ambitions of the person using it. Our service and product lines ensure that each individual story matters. Remain within Reach We feel it is important that both our people and our products remain accessible and available to you. We strive to create a unique place in the market: offering you more than just best-in-class products. We are here to support you. To make it easier for you, the complex rehab professional, to meet the needs of your clients. Better by Design
