Medical Device Mechanical Engineer
Michigan, Kalamazoo-Battle Creek
Excellent Opportunity with Global Fortune 300 Medical Device Organization!
Medical Device Mechanical Engineer
Located in Kalamazoo MI
Great Career Advancement Opportunities
Relocation Assistance Available
Summary of Position
As a Staff Engineer in this role, you will be responsible to design, develop, modify, and evaluate both reusable and disposable mechanical and/or electromechanical medical devices (including components, assemblies, and sub systems), under specific time, regulatory and cost constraints. The immediate need of this role is to provide design support of plastic, single use devices but will likely grow into a role that requires both plastic and machine design support. You will work closely with peers to develop designs that meets customer and system requirements. Following defined design practices and the use of sound engineering principles, you will ensure that the designed medical devices are safe, robust and user friendly. You will be responsible for creation, CAD modelling, prototyping and testing your designs. You will work alongside other Design Engineers (Mechanical, Electrical and Software) to ensure outstanding products are created. Additionally, you will work with supporting functions (Project Management, Operations, Sourcing, Quality, Regulatory, etc.) as a key part of the overall product development team.
Conducts research: Identifies, presents and progresses new opportunities through the research process, including conducting feasibility studies on new designs and Investigating new technologies
Participates in project planning and estimating activities on a macro (e.G. Block diagram from project start to finish) up to a micro level (task level on a day by day basis)
Develops and specifies precise new product functional requirements and testing strategies according to user needs, internal and external standards and regulatory requirements.
Designs, tests and integrates components and sub-assemblies to produce final designs
Identifies root causes of issues, determines potential solutions, and evaluates them against requirements
Ensures the integrity and security of company intellectual property and confidential data
Follows the company s standards for product development and quality process and complies with quality management system procedures
Ensures that sound application of engineering principles, practices and procedures are being used and design intent is being achieved
Works closely and collaboratively with other members of the development team in a fast-paced team environment
Achieves relevant performance, time-to-market objectives, and product and project cost targets, all while achieving product quality goals
Evaluates the design' s overall effectiveness, cost, reliability and safety
Creates and reviews material part specifications and bills of materials
Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability
Utilizes Ansys FEA software to optimize product robustness prior to prototyping and testing
Utilizes PRO-E CAD to model new designs and produce detailed engineering drawings
B.S. In mechanical engineering or related engineering curriculum.
At least 5 years of industry experience in mechanical or electro mechanical design with proven ability to take designs from concept to production
At least 3 years industry experience designing plastic devices (preferably but not required sterile single use medical devices).
Working knowledge of mold flowing analysis tools.
Working knowledge of 3D modelling software.
Working knowledge of finite element analysis software.
Ability to convert complex technical issues to actionable tasks and then to successful outcomes through personal action or delegation
Demonstrated high level of technical competency in product design & problem-solving skills.
Ability to effectively work & collaborate in a global team setting
Versatility, flexibility, ability to manage priorities and workflow
Excellent analytical, problem solving, and organizational skills.
Effective verbal and written communication skills; ability to present issues, plans and objectives.
Strong interpersonal skills to work effectively with different disciplines and customers.
Preferred technical competencies and experience:
Medical device design experience or experience in another highly regulated industry
Experience in injection mold product design
Experience in mold flow analysis tools
Experience with electro-mechanical devices
Experience using PRO-E software
Experience using ANSYS software