- Consults with client to define project scope, develops a preliminary plan of investigation, and determines project specifications such as cost, time and sample requirements by analyzing customer input.
- Work with the engineering team to ensure specification compliance in the areas of; design, system performance and delivery criteria.
- Help develop the engineering documentation required.
- Develop the manufacturing process collaboration with the PMCM Mfg. Eng. Team.
- Coordinate mold tool manufacturing, design and qualification.
- Participate in design reviews internally and with external suppliers and customers.
- Communicate project status and results to external customers, management, and internal customers through frequent contact and communication efforts.
- Follow ISO 13485, FDA Medical Device Directives and other applicable standards.
- Create and maintain technical files including design history folders and project deliverables.
- Investigate new materials/processes/equipment to further broaden the company’s capabilities.
- Assist with troubleshooting and root cause investigations.
- Provides direction for qualification protocols (test plans) such as design verification test plans.
- Bachelor’s Degree in Manufacturing Engineering or related technical field.
- 3+ years of relevant experience in an engineering role.
- 3+ years’ experience with project management.
- 3+ years’ experience in Microsoft products (i.e. Excel, MS Project, Power Point etc.)
- 2+ years of new product development experience.
- Bachelor's degree in Manufacturing/Electrical Engineering.
- Design experience utilizing SolidWorks 2019.
- PMP & proficiency in MS Project/Celoxis.
- 3+ years’ experience SolidWorks 3D modeling software.
Skills and Abilities:
- Familiar with the injection molding process. Insert/over molding experience is preferred.
- Able to read work instructions and assembly/component level drawings.
- Excellent written and oral communication skills; must have the ability to communicate effectively and project a professional image when giving and taking information in writing and in person.
- Must have a Proactive mentality and ability to know when to escalate issues if required.
- Demonstrate strong inter-departmental co-operation skills.
- Must have strong technical, analytical and extensive problem-solving skills.
- Familiarity with ISO 13485, FDA Medical Device Directives and other applicable standards preferred.
- Six Sigma black/green belt preferred.