Senior Product Development Engineer - Design Transfer

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