Manufacturing Engineer

SCIENTIA VASCULAR INC • West Valley City, UT

13d

About The Position

This position will work closely with the Research and Development and Manufacturing Engineering teams to bridge the development of new products from R&D into production. As a Transfer Engineer you will develop new manufacturing processes, drive product transfers, optimize manufacturing processes, and scale manufacturing line capacity all while ensuring quality, safety, and cost targets are met.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field
• Ability to interact professionally and in a collaborative manner across all organizational levels
• Minimum of 3 years experience working in a regulated industry, medical device preferred
• Understanding of cGMP and Medical Device manufacturing regulations preferred
• Solid problem-solving, organization, and analytical critical thinking skills with an emphasis on statistical data analysis.
• Ability to lead a project from early ideation through to full completion
• Strong written and oral communication skills
• Proficient in Excel and Word

Responsibilities

• Collaborate cross-functionally to facilitate transition of new products from early ideation through to fully implemented manufacturing processes
• Work cooperatively with research and development, quality, operations, regulatory, and marketing to ensure project success
• Provide expertise in specification setting, equipment procurement, build documentation, work instructions, process validation, and personnel training on manufacturing equipment/processes
• Completes process validation activities for manufacturing processes. Ensuring compliance with applicable FDA and international regulatory standards
• Performs troubleshooting on new products/processes related to design, material, equipment, and process. Must be comfortable working in a hands-on manufacturing environment
• Designs, performs, and analyzes engineering tests and experiments
• Designs, procures, and fabricates tooling and fixtures
• Contributes to intellectual property position of company by inventing concepts and designs for new products/processes and submitting idea disclosures
• May train and/or provide work direction to technicians
• Additional duties and responsibilities as assigned

Benefits

• Medical, Dental, Vision insurance
• Generous Paid Time Off (PTO)
• Paid Parental Leave
• Paid Holidays
• 401k Plan (with a generous employer match)
• Life Insurance (company paid)
• Short-Term & Long-Term Disability Insurance (company paid)
• Subscription to Calm.com
• Employee Assistance Program
• An environment of belonging where everyone can thrive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level