Senior Product Development Engineer

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