Job description
Roles & Responsibilities:
- Design support for procedure pack products for medical applications in a regulated environment.
- Create robust design solutions that address broad development problems involving class II disposable medical devices and accessories.
- Support sustaining engineering programs to support new and existing products to ensure sustainable and stable operations of production. Identify areas that require additional investigation.
- Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.
- Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
- Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business.
- Document and support decisions using engineering analysis and data.
- Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements.
- Utilize project management and lean sigma methodologies, including DMAIC and MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices).
- Utilize design development, analysis and statistical tools, to include Pro/E, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R & R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
- Interface with suppliers, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products.
- Create and communicate project plans, tasks and deliverables, and manage time to meet project deadlines.
- Lead troubleshooting and problem-solving efforts related to development projects.
- Support decisions through thorough engineering analysis and data.
- Proven communication skills and ability to lead within a multi-functional team environment
- A demonstrated capacity for solving problems through creative designs
- Knowledge and experience using DFMECA FMEA, DOE.
- Knowledge and experience with statistical analysis (Minitab, ANOVA)
- Knowledge of MDR regulations and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices);
- utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why's, Ishikawa (Fishbone).
- 2 years progressive mechanical design experience in a regulated medical industry
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