Job Type: Full Time
Location: Kalamazoo, MI
We are looking for a talented individual to join our dynamic Keystone Product Development team located in Kalamazoo, MI. This motivated, self-starter must have an engineering degree, product development and design experience.
The successful candidate must be capable of leading the development of innovative, functional, cost effective product concepts and product designs and has a full understanding in the application of design controls and development process. The candidate must have a “can do” attitude, and possess creative problem-solving skills. This candidate must have great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress. Excellent interpersonal skills while working with high customer visibility are also critical to success in this opportunity.
Job Duties
- Lead multiple complex projects
- Creates design controls to support customer User Needs and Intended Use Statement
- Ability to develop designs while keeping DFM, cost, reliability and timing in mind
- Use established procedures and process maps for new product development projects
- Demonstrated ability to use creative solutions to solve complex problems.
- Develops test methods and performs design verification testing utilizing statistical methods
- Develops prototypes for development testing to prove concept of design using 3D prototyping methods
- Performs development / prototype builds and assists in developing MAP’s
- Writes easily understood test protocols and test reports to support design controls
- Performs tolerance analysis of mechanical designs and fully understands current drawing standards
- Conducts and participates in customer and internal design reviews
- Assists in updating and maintaining the Product Development process
- Create and communicate project plans, tasks and deliverable to customers and senior management
- Interface with multiple suppliers for prototyping, pilot and production builds
- Ability to perform Risk Management and FMEA tasks
- Create and qualify test fixtures for development testing and assist with assembly test fixture development
- Ability to drive tasks to completion
- Mentor and train junior engineers
- Manage co-ops and interns
- Supports transfer of design to manufacturing
- Maintains Design History File per established procedures and best practices
- Perform other duties as assigned
Requirements and Qualifications
- Minimum BS in an Engineering discipline is required. No Engineering Technology Degrees will be considered.
- Minimum 7 years’ experience in an engineering environment
- Must have experience in the Medical Device Industry.
- CAD experience is required, using SolidWorks and/or ProEngineer
- 3D prototyping experience is a requirement
- Experience with single use disposable products
- Statistical analysis and methods experience is required
- Finite Elemental Analysis and/or Computational Fluid Dynamics experience is a plus
- GD&T knowledge is preferred
- Strong personal computer skills, including experience with MS office and MS Project
- Excellent communication and people skills is required
- Proof of degree and transcripts may be requested
- Candidate must pass background check and drug screen
- Must be authorized to work in the United States (this job does not offer sponsorship)
Benefits
- Excellent full-time benefits including comprehensive medical coverage, dental and vision options
- Company paid life insurance, short term disability and long-term disability insurance
- Retirement savings plan with company match
- Paid Time Off and holidays
- Educational Assistance
Schedule
- Monday through Friday
Work Remotely
- TBD based upon candidates work ethic and performance. Minimum of 3 days in office would be required.
