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Senior Product Development Engineer
3 months ago
Job Purpose:
Responsible for developing new medical devices
Duties:
- Act as technical lead in the development of new products, primarily class I and class II single-use medical devices
- Lead Project Management activities such as budgets, resources, timelines, and deliverables
- Provide primary interface to customer for communication of project status and plans
- Develop and define product and customer requirements
- Lead product and process risk assessments
- Participate in design reviews
- Write and execute protocols for design verification and validation
- Lead test method development and have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
- Oversee and perform testing and inspection of prototypes and pre-production products
- Analyze test data, interpret results and formulate conclusions
- Lead investigation of device failures to determine root cause and corrective action
- Develop assembly methods and oversee prototype builds
- Lead process development activities, write work instructions, and develop in process inspection procedures
- Generate CAD models for test or assembly fixtures
- Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
- Investigate, evaluate and select product materials
- Prepare detailed component and assembly drawings
- Prepare documentation to support design history files and regulatory submissions
- Maintain DHF and ensure documents are complete, accurate, and current
- Communicate effectively with customers and vendors in a technical capacity
Skills/Qualifications:
- BS in Engineering or equivalent technical degree
- 5 - 12 years relevant experience in product development, preferred
- Proven ability to lead a product development program
- Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software
- Experience with plastics and/or silicones, particularly injection molding
- Knowledge of medical device regulations (FDA/ISO)
Personal Attributes:
- Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
- Comfortable and productive in a fast-paced, entrepreneurial environment
- A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients
- Commitment to excellence and quality service to external and internal customer
- Commitment to established policies and procedures, while contributing to continuous improvements
- Excellent communication skills (oral and written)
- Proficient (or better) computer skills, including Excel and Word