The Engineer will be expected to provide hands on engineering support for Operations. Interacts with customers and provides support for Engineering and Quality Systems.
- Follows and develops Quality and Regulatory requirements including company policies, procedures, and appropriate regulatory requirements
- Develops and Executes Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with company procedures and guidelines
- Communicates ideas, information, and recommendations clearly, effectively and frequently (oral and written) within company, with outside suppliers or partners and with company customers during formal and informal interactions
- Prepares or review documentation with a high degree of accuracy, completeness, and effectiveness using common company engineering tools & templates were available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis
- Applies Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, and supports the execution of improvement efforts or reduce waste in all manufacturing and business process
- Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions
- Plans and executes project activities within a cross functional team. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives.
- Exhibits the company values (Customer focus, Continuous Improvement, Performance, Accountability, Teamwork and Integrity) in all activities
- Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
- Demonstrates technical ability through the application of engineering skills, approaches and knowledge
- Performs all duties and directs others creating a safe working environment for our employees and our communities
- Performs other duties as necessary
- Minimum of bachelor’s degree in engineering or equivalent
- 5 years working experience in manufacturing environment, preferably in medical device with increasing responsibility