Job DescriptionSupport product data process development of products for medical devices through the creation and maintenance of digital product processes, testing enterprise systems and business processes, maintaining software validation documents and specifications, testing enterprise systems and business processes. Work closely with Operations, R&D, Quality, Regulatory and IT to optimize engineering processes, integrate digital tools, and enhance data continuity from concept through end-of-life. Job duties:
- Support validation of enterprise system and business processes.
- Collaborate with fellow associates and other departments to solve product data and process issues.
- Investigate product process issues in data systems.
- Troubleshoot PLM-related issues and provide user support.
- Support data management for pilot production, product development, sustaining engineering, and planning.
- Execute validation of product and process systems and data.
- Support organizational training in the areas of enterprise systems usage and data-related business processes.
- Analyze data and improve processes to ensure robust/repeatable data management processes.
- Review and develop product process data and documents (e.g., Work Instructions, Build Records, BOMs, etc.).
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Qualifications- Bachelor of Science in Mechanical, Manufacturing, or Industrial Engineering, or a related field of study.
- Minimum of two (2) years of related experience.
- Strong written and verbal communication skills.
- Proficient computer skills including Word, Excel, PowerPoint, Outlook, and Teams.
- Good problem solving and conflict management skills.
- Ability to work both independently and as a team member with moderate direction.
Desired Qualifications- Proficiency in SolidWorks (and/or CAD).
- Experience with enterprise systems such as PLM.
- Project management skills.
- Knowledge of validation processes in medical device industry environment.
Salary Range$80,000 - $94,000 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
