Principal Operations Engineer
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
The Principal Operations Engineer provides process development support for R&D projects along with Manufacturing support for existing system production. This individual will utilize design for manufacturing (DFMA) methods and tools to create processes and designs that are robust and able to be manufactured economically, lead projects which drive improved cost, quality and the continued supply of product for worldwide operations, and use creativity and accepted engineering practices to design and develop creative engineering solutions for complex medical devices. This role will manage projects of varied scope provide mentorship to Operations Engineers, and lead and provide work direction to junior Engineers and Technicians.
Primary Duties and Responsibilities
Technical Development and Analysis
• Identifies released product design and manufacturing process issues, evaluates critical nature, determines root cause, develops design and process solutions, and implements solution.
• Designs, develops, prototypes, measures, and tests mechanical hardware and consumables used in electro-mechanical, software controlled devices
• Works cross-functionally to ensure design addresses internal & external supplier needs
• Effectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for regulatory submissions
• Provides hands-on support for products from design and process development to commercial release and end of product life
• Maintain skills and awareness of technical improvements and competition advancements
Project Management and Documentation
• Rigorous documentation for all phases of projects, including design specifications, manufacturing requirements, verification test plans, qualifications, project schedules, drawings, and change orders associated with medical devices and consumable products.
• Routine communication with peers and supervisors including documentation of work, meetings, and decisions
• Develops & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects
• Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion
• Direct outside contract personnel as needed for completion of specific tasks.
Manufacturing Engineering & Technician Supervision
• Provide work direction, coaching, and guidance to manufacturing technicians and junior engineers
• Promote employee development and foster growth of employees through:
o Performance Management
o Skills development
o Continuous one-on-one feedback
o Bi-annual appraisal of individual performance
o Recognition and motivational techniques/tools to drive high levels of employee performance and engagement
• Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes
• Identify resource needs (human, equipment, etc.) and communicate to management for improvement as needed, addition of capabilities, and future growth projections to support a growing business.
Quality, Compliance, and Regulated Practices
• Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
• Ensures product meet requirements regulated by FDA, UL, CE and other governing bodies
• Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications
Qualifications (Knowledge, Skills & Abilities):
• BS in an engineering discipline
• 10+ years of experience in a Manufacturing/Operations Engineering role in a regulated industry
• 7+ years medical device experience
• Experience managing or leading others in a similar capacity, and/or demonstrated experience working cross-functionally in the engineering / test environment.
• Project management experience, with the ability to coordinate multiple projects simultaneously
• Experience implementing design changes with Contract Manufacturers
• Knowledge of QSR, ISO/EN and Quality System Standards
• Strong interpersonal and communication skills
• Technical writing skills
• Demonstrated organizational and administrative skills.
• Ability to prioritize and handle multiple tasks.
• Strong problem solving skills with the ability to interpret drawings, schematics, and specifications.
• Moderate to high level of computer proficiency including MS Office Suite, SolidWorks, ERP Systems
• Ability to assimilate technical concepts quickly and present technical information clearly and concisely for technical and non-technical audiences.
• Process development experience
• Ability to travel up to 20% (domestic and international)
• MS Manufacturing / Mechanical / Chemical Engineering