To manage multiple facets of engineering-based projects related to new product development and continuous improvement on FDA Group 2, ISO Class A/B/C medical devices while facilitating cross departmental communication regarding timelines, budget, and acquisition of parts.
Requirements
- Maintain overall timeline of the groupās projects relative to one another to prevent delays due to timing conflicts
- Serve as mentor to project management staff, providing direction and decisive decision making as needed
- Independently construct and maintain project timelines and Design History Files (DHFās)
- Facilitate meetings for product development and design reviews including action item assignment and follow-up
- Maintain active and regular communication with domestic and international contract manufacturers on project updates
- Facilitate cross functional team meetings and presentations
- Technical document input and review with Product Management Team
- Work with Project Team and Product Management Team to facilitate inventory planning/tracking necessary for product launches and changes
- Create Form Fit Function checklist and plan for all assigned projects
- Collect operational and test data, evaluate results, and compile reports
- Generation of project budget and tracking of project cost, including target and actual
- Effectively communicate project status for leadership teams
- Ensure adherence and conformity to design control policies/procedures, planning, execution and coordination of new products
- Present new product ideas and solutions conceptually or via prototypes with cost estimates and market feasibility to R&D Leadership team
- Play an active role in the development of new products and enhancements to existing products while utilizing feedback globally to focus on the Corporate vision
- Complete continuous improvement Engineering Change Requests (ECR's) assigned on recently launched products
- Facilitate productivity of multiple teams with R&D such as Mechanical Engineering, Industrial Designs, Drafting, Test Lab and Machine Shop
- Develop strong working relationships with all functional teams including Sales, Marketing, Manufacturing, Supply Chain, and Distribution
- Develop familiarity with regulatory requirements to make compliance recommendations
- Develop working knowledge of Pride Test Procedures within specific Area of Responsibility (AOR)
- Review test request submissions and testing units/components for completeness, accuracy, and test worthy condition
- Apply an understanding of design change protocol, demonstrate good business judgment and support product development in the best interest of Pride sales efforts
- Attend trade shows as needed
- Ensure all safety and security rules are strictly observed and any accidents, incidents or injuries are promptly reported to management
- Attend the Annual C-TPAT Security Training
- Focus on continuous improvement, and consistently demonstrate good business judgment
- Work effectively with all Pride departments to exceed internal and external expectations
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability insurance
- Long-term disability insurance
