Product Transfer Engineer - Medical Device Manufacturing

Job Description

• Support design change and technology transfer activities for interplant transfers and new product introduction.
• Coordinate and maintain change management process to ensure changes are reviewed with multifunctional teams and implemented within the plant to meet requirements of the Device Master Record.
• Establish configuration of plant data packages in SAP Product Lifecycle Management (PLM). Ensure efficient creation and implementation of plant Quality, Engineering, and data packages per Straumann standards.
• Development of quality plans and measurement procedures for the areas of incoming goods inspection and quality assurance. Develop and write processes and generate ECOs as required.
• Drive qualification / validation efforts as defined in Validation Master Plan, including qualifying equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing inspection activities. Provide complete, accurate, and well-organized documentation for requirements, plans, reports, PFMEA’s, checklists, etc. in conjunction with the validation team.
• Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems; Implement approved changes using sound engineering principles and fully document them in compliance with QSR and ISO standards.
• Other duties as may be assigned by the Head of Quality Engineering.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 5 years of experience as an engineer in a related field.
• Working knowledge of validation, failure investigation, risk management, GR&R, auditing, quality assurance, and quality systems in a medical device environment.
• Excellent knowledge of GMP and ISO standards.
• Must be meticulous, conscientious, customer service-oriented, a team player-learner with strong written and oral communication skills.
• The ability to work independently in a dynamic manufacturing environment.
• Strong skills for planning, time management, organization and presentation.
• Word, Excel, Project, statistical software computer skills.
• Ability to develop project plans and execute to them. Experience leading multiple projects a plus.
• Knowledge of database applications (SAP/PLM) is an advantage.
• CNC machining experience a plus.

Additional Information

Straumann Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.